Trials (University Medical Center Groningen Comprehensive Cancer Center)

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Revision as of 18:25, 5 December 2023 by Francine (talk | contribs) (Created page with "{{forpatients}} {{forresearchers}} {{forproviders}} Go back to University Medical Center Groningen Comprehensive Cancer Center page '''NCTID''': NCT03719690 '''Title''': Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy '''Study Summary''': An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). Th...")
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NCTID: NCT03719690

Title: Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy 
Study Summary: An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up. 
Sponsor: Kura Oncology, Inc. 
Intervention: Tipifarnib 
Start Date: 2018-11-05 
Last Updated: 2022-11-09 
Number of Patients: 284 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: HRAS Gene Mutation 

NCTID: NCT00626990

Title: Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.  PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: temozolomide 
Start Date: 2007-12 
Last Updated: 2023-09-11 
Number of Patients: 751 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Brain and Central Nervous System Tumors 

NCTID: NCT05171075

Title: A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE 
Study Summary: This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia) 
Sponsor: Anthos Therapeutics, Inc. 
Intervention: Abelacimab 
Start Date: 2022-09-27 
Last Updated: 2023-11-21 
Number of Patients: 1020 
Recruitment Status: RECRUITING 
Condition: Venous Thromboembolism 

NCTID: NCT00112554

Title: Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.  PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia. 
Sponsor: Vion Pharmaceuticals 
Intervention: cytarabine 
Start Date: 2005-03 
Last Updated: 2013-11-06 
Number of Patients: 420 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT00089856

Title: GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer 
Study Summary: The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past. 
Sponsor: Cell Genesys 
Intervention: Immunotherapy with allogeneic prostate vaccine 
Start Date: 2004-07 
Last Updated: 2008-11-05 
Number of Patients: 626 
Recruitment Status: TERMINATED 
Condition: Prostate Cancer 

NCTID: NCT00052156

Title: Vaccine Therapy for Patients With Stage IV Melanoma 
Study Summary: This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma. 
Sponsor: CancerVax Corporation 
Intervention: CancerVax vaccine (CANVAXIN) 
Start Date: NA 
Last Updated: 2005-06-24 
Number of Patients: 670 
Recruitment Status: UNKNOWN 
Condition: Malignant Melanoma 

NCTID: NCT04996875

Title: (Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis 
Study Summary: This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL). 
Sponsor: Cogent Biosciences, Inc. 
Intervention: bezuclastinib 
Start Date: 2021-11-09 
Last Updated: 2023-10-25 
Number of Patients: 120 
Recruitment Status: RECRUITING 
Condition: Advanced Systemic Mastocytosis (AdvSM) 

NCTID: NCT00003783

Title: Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and combining drugs in different ways may kill more cancer cells.  PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 1999-03 
Last Updated: 2014-07-28 
Number of Patients: 36 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT01533207

Title: Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery 
Study Summary: This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma. 
Sponsor: Gynecologic Oncology Group 
Intervention: Clinical Observation 
Start Date: 2012-06-04 
Last Updated: 2020-04-28 
Number of Patients: 38 
Recruitment Status: TERMINATED 
Condition: Stage I Uterine Sarcoma AJCC v7 

NCTID: NCT00003119

Title: Surgery in Treating Children With Neuroblastoma 
Study Summary: RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.  PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 1998-03 
Last Updated: 2017-03-13 
Number of Patients: 968 
Recruitment Status: COMPLETED 
Condition: Neuroblastoma 

NCTID: NCT05382286

Title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer 
Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab Govitecan-hziy 
Start Date: 2022-07-25 
Last Updated: 2023-11-15 
Number of Patients: 440 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer 

NCTID: NCT04211337

Title: A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer 
Study Summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib. 
Sponsor: Loxo Oncology, Inc. 
Intervention: Selpercatinib 
Start Date: 2020-02-11 
Last Updated: 2023-10-30 
Number of Patients: 291 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Medullary Thyroid Cancer 

NCTID: NCT04980222

Title: A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma 
Study Summary: This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment. 
Sponsor: Hoffmann-La Roche 
Intervention: Glofitamab 
Start Date: 2022-03-22 
Last Updated: 2023-11-07 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Lymphoma 

NCTID: NCT05208047

Title: (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors 
Study Summary: This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. 
Sponsor: Cogent Biosciences, Inc. 
Intervention: CGT9486 plus sunitinib 
Start Date: 2022-04-14 
Last Updated: 2023-11-28 
Number of Patients: 426 
Recruitment Status: RECRUITING 
Condition: Advanced Gastrointestinal Stromal Tumors 

NCTID: NCT04663347

Title: Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) 
Study Summary: A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL). 
Sponsor: Genmab 
Intervention: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone 
Start Date: 2020-11-03 
Last Updated: 2023-08-08 
Number of Patients: 662 
Recruitment Status: RECRUITING 
Condition: Diffuse Large B-Cell Lymphoma 

NCTID: NCT03975647

Title: A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer 
Study Summary: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.  Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.  Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle. 
Sponsor: Seagen Inc. 
Intervention: tucatinib 
Start Date: 2019-10-02 
Last Updated: 2023-11-21 
Number of Patients: 565 
Recruitment Status: RECRUITING 
Condition: HER2-positive Breast Cancer 

NCTID: NCT03037385

Title: Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors 
Study Summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors. 
Sponsor: Hoffmann-La Roche 
Intervention: pralsetinib (BLU-667) 
Start Date: 2017-03-17 
Last Updated: 2023-11-27 
Number of Patients: 589 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: RET-altered Non Small Cell Lung Cancer 

NCTID: NCT05173987

Title: Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) 
Study Summary: The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.  The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: pembrolizumab 
Start Date: 2022-02-03 
Last Updated: 2023-11-09 
Number of Patients: 280 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Endometrial Neoplasms 

NCTID: NCT03860883

Title: Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma 
Study Summary: Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life. 
Sponsor: Melanoma and Skin Cancer Trials Limited 
Intervention: Wide Local Excision = 1cm Margin 
Start Date: 2019-12-17 
Last Updated: 2023-10-19 
Number of Patients: 2998 
Recruitment Status: RECRUITING 
Condition: Cutaneous Melanoma, Stage II 

NCTID: NCT01479283

Title: Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) 
Study Summary: The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever international multi-center randomized controlled trial in bone cancer surgery. In order to avoid amputation for bone cancer in the leg, complex limb-saving operations are performed. However, infections with devastating complications following surgery are common. Surgeons from across the world will randomize patients to receive either short- or long-duration antibiotic regimens after surgery with the goal of identifying the best regimen to reduce these infections. 
Sponsor: McMaster University 
Intervention: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen 
Start Date: 2013-01 
Last Updated: 2021-03-11 
Number of Patients: 602 
Recruitment Status: COMPLETED 
Condition: Infection 

NCTID: NCT00003671

Title: Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: asparaginase 
Start Date: 1998-12 
Last Updated: 2014-07-25 
Number of Patients: 59 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT00003739

Title: Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy 
Study Summary: RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person’s immune system recover from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus G-CSF is more effective than antibiotic therapy alone for treating side effects caused by chemotherapy.  PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 1999-03 
Last Updated: 2014-02-14 
Number of Patients: 67 
Recruitment Status: COMPLETED 
Condition: Fever, Sweats, and Hot Flashes 

NCTID: NCT00019422

Title: Lobradimil and Carboplatin in Treating Children With Brain Tumors 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.  PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment. 
Sponsor: National Cancer Institute (NCI) 
Intervention: carboplatin 
Start Date: 1998-03 
Last Updated: 2013-08-16 
Number of Patients: NA 
Recruitment Status: COMPLETED 
Condition: Brain and Central Nervous System Tumors 

NCTID: NCT01796171

Title: A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma 
Study Summary: This study is a phase I/II open-label study in patients with relapsed indolent NHL (Part A) or relapsed/refractory FL (Part B). Part A of the study assessed the safety and preliminary efficacy. This seamless design study now has four parts: 1) Part A, Ph I - dose escalation, 2) Part A, Ph II - dose expansion, 3) Part B, Ph II randomized - refinement of dose, and 4) Part B and C, Phase II, single-arm. As of August 7, 2020, patients are enrolling in the fourth part of the study. 
Sponsor: Nordic Nanovector 
Intervention: Betalutin 
Start Date: 2012-12 
Last Updated: 2022-09-14 
Number of Patients: 191 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-Hodgkin Lymphoma 

NCTID: NCT00088803

Title: DNA Variations in the Gene in Young Patients With Wilms’ Tumor 
Study Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.  PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young patients with Wilms’ tumor. 
Sponsor: Children’s Oncology Group 
Intervention: molecular genetic technique 
Start Date: 2004-08 
Last Updated: 2016-05-19 
Number of Patients: 471 
Recruitment Status: COMPLETED 
Condition: Kidney Cancer 

NCTID: NCT03940703

Title: A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) 
Study Summary: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC). 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Tepotinib 
Start Date: 2019-09-19 
Last Updated: 2023-08-29 
Number of Patients: 120 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT03361865

Title: Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307) 
Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma. 
Sponsor: Incyte Corporation 
Intervention: Pembrolizumab 
Start Date: 2017-12-04 
Last Updated: 2021-12-16 
Number of Patients: 93 
Recruitment Status: COMPLETED 
Condition: UC (Urothelial Cancer) 

NCTID: NCT05118789

Title: A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) 
Study Summary: Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors.  Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors.  Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. 
Sponsor: Nuvalent Inc. 
Intervention: NVL-520 
Start Date: 2022-01-04 
Last Updated: 2023-11-07 
Number of Patients: 359 
Recruitment Status: RECRUITING 
Condition: Locally Advanced Solid Tumor 

NCTID: NCT00006462

Title: Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.  PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: gemcitabine hydrochloride 
Start Date: 2001-04 
Last Updated: 2014-02-20 
Number of Patients: 32 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT02617589

Title: An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) 
Study Summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy. 
Sponsor: Bristol-Myers Squibb 
Intervention: Nivolumab 
Start Date: 2016-03-01 
Last Updated: 2023-03-28 
Number of Patients: 560 
Recruitment Status: COMPLETED 
Condition: Brain Cancer 

NCTID: NCT03149549

Title: PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors 
Study Summary: The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001  PROBODY is a trademark of CytomX Therapeutics, Inc 
Sponsor: CytomX Therapeutics 
Intervention: CX-2009 
Start Date: 2017-06-01 
Last Updated: 2021-08-04 
Number of Patients: 99 
Recruitment Status: COMPLETED 
Condition: Solid Tumor, Adult 

NCTID: NCT00932893

Title: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene 
Study Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug. 
Sponsor: Pfizer 
Intervention: PF-02341066 
Start Date: 2009-09 
Last Updated: 2017-01-02 
Number of Patients: 347 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT00003093

Title: Combination Chemotherapy in Treating Children With Neuroblastoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma.  PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 1988-03 
Last Updated: 2014-08-01 
Number of Patients: 573 
Recruitment Status: COMPLETED 
Condition: Neuroblastoma 

NCTID: NCT02725268

Title: A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer 
Study Summary: The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone. 
Sponsor: Millennium Pharmaceuticals, Inc. 
Intervention: Paclitaxel 
Start Date: 2016-04-01 
Last Updated: 2021-11-24 
Number of Patients: 241 
Recruitment Status: COMPLETED 
Condition: Endometrial Neoplasms 

NCTID: NCT00003593

Title: Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.  PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome. 
Sponsor: Children’s Oncology Group 
Intervention: asparaginase 
Start Date: 1999-06 
Last Updated: 2013-06-27 
Number of Patients: 254 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT00003745

Title: Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas 
Study Summary: Phase II trial to study the effectiveness of topotecan in treating children who have recurrent, relapsed, or refractory sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 
Sponsor: National Cancer Institute (NCI) 
Intervention: topotecan hydrochloride 
Start Date: 1999-05 
Last Updated: 2013-02-05 
Number of Patients: 125 
Recruitment Status: COMPLETED 
Condition: Sarcoma 

NCTID: NCT02375204

Title: Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors 
Study Summary: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors. 
Sponsor: Alliance for Clinical Trials in Oncology 
Intervention: paclitaxel 
Start Date: 2015-08-05 
Last Updated: 2023-08-31 
Number of Patients: 420 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Germ Cell Tumor 

NCTID: NCT02718417

Title: Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) 
Study Summary: This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.  The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients. 
Sponsor: Pfizer 
Intervention: carboplatin 
Start Date: 2016-05-19 
Last Updated: 2020-07-14 
Number of Patients: 998 
Recruitment Status: TERMINATED 
Condition: Ovarian Cancer 

NCTID: NCT02039726

Title: (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive 
Study Summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy. 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: Quizartinib 
Start Date: 2014-05 
Last Updated: 2021-02-24 
Number of Patients: 367 
Recruitment Status: COMPLETED 
Condition: AML 

NCTID: NCT01212991

Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer 
Study Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. 
Sponsor: Pfizer 
Intervention: Enzalutamide 
Start Date: 2010-09-16 
Last Updated: 2020-03-17 
Number of Patients: 1717 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT05041309

Title: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells 
Study Summary: The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies. 
Sponsor: Kite, A Gilead Company 
Intervention: Axicabtagene Ciloleucel 
Start Date: 2021-12-15 
Last Updated: 2023-11-07 
Number of Patients: 700 
Recruitment Status: ENROLLING_BY_INVITATION 
Condition: Solid and Hematological Malignancies 

NCTID: NCT02273375

Title: Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC 
Study Summary: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer. 
Sponsor: Canadian Cancer Trials Group 
Intervention: MEDI4736 
Start Date: 2015-02-24 
Last Updated: 2023-10-27 
Number of Patients: 1415 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT04950075

Title: Study of INBRX-109 in Conventional Chondrosarcoma 
Study Summary: Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. 
Sponsor: Inhibrx, Inc. 
Intervention: INBRX-109 
Start Date: 2021-09-23 
Last Updated: 2023-11-08 
Number of Patients: 201 
Recruitment Status: RECRUITING 
Condition: Conventional Chondrosarcoma 

NCTID: NCT00052130

Title: Vaccine Therapy for Patients With Stage III Melanoma 
Study Summary: This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma. 
Sponsor: CancerVax Corporation 
Intervention: CancerVax vaccine (CANVAXIN) 
Start Date: NA 
Last Updated: 2005-06-24 
Number of Patients: 1118 
Recruitment Status: UNKNOWN 
Condition: Malignant Melanoma 

NCTID: NCT03580655

Title: (PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis 
Study Summary: This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL) 
Sponsor: Blueprint Medicines Corporation 
Intervention: Avapritinib 
Start Date: 2018-11-21 
Last Updated: 2023-08-02 
Number of Patients: 103 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced Systemic Mastocytosis 

NCTID: NCT00002851

Title: Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed 
Study Summary: RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.  PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: adjuvant therapy 
Start Date: 1996-07 
Last Updated: 2010-01-29 
Number of Patients: 4000 
Recruitment Status: UNKNOWN 
Condition: Breast Cancer 

NCTID: NCT01986348

Title: Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas 
Study Summary: This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas. 
Sponsor: Karyopharm Therapeutics Inc 
Intervention: Selinexor 
Start Date: 2014-03-03 
Last Updated: 2023-01-26 
Number of Patients: 76 
Recruitment Status: TERMINATED 
Condition: Glioblastoma 

NCTID: NCT04250155

Title: An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors 
Study Summary: This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors. 
Sponsor: Genentech, Inc. 
Intervention: XmAb24306 
Start Date: 2020-03-09 
Last Updated: 2023-11-24 
Number of Patients: 250 
Recruitment Status: RECRUITING 
Condition: Solid Tumors 

NCTID: NCT00547651

Title: AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy 
Study Summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer. 
Sponsor: Celgene 
Intervention: Amrubicin 
Start Date: 2007-09-01 
Last Updated: 2019-11-06 
Number of Patients: 637 
Recruitment Status: COMPLETED 
Condition: Small Cell Lung Cancer 

NCTID: NCT03915951

Title: An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer 
Study Summary: This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC). Patients who are either treatment-naïve, OR who have received 1) first-line treatment with standard platinum-based chemotherapy, OR 2) first-line treatment with an anti-programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) inhibitor given alone or in combination with platinum-based chemotherapy will be enrolled. 
Sponsor: Pfizer 
Intervention: encorafenib 
Start Date: 2019-06-04 
Last Updated: 2023-10-30 
Number of Patients: 98 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT02319837

Title: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) 
Study Summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.  The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format. 
Sponsor: Pfizer 
Intervention: Enzalutamide 
Start Date: 2014-12-17 
Last Updated: 2023-08-08 
Number of Patients: 1068 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Hormone Sensitive Prostate Cancer 

NCTID: NCT00003937

Title: Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy.  PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma. 
Sponsor: Children’s Oncology Group 
Intervention: cisplatin 
Start Date: 1999-09 
Last Updated: 2014-08-05 
Number of Patients: 253 
Recruitment Status: COMPLETED 
Condition: Cardiac Toxicity 

NCTID: NCT01059630

Title: A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin’s Lymphoma (GADOLIN) 
Study Summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin’s lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years’ safety follow-up from last dose). 
Sponsor: Genentech, Inc. 
Intervention: Obinutuzumab 
Start Date: 2010-04-30 
Last Updated: 2020-01-13 
Number of Patients: 413 
Recruitment Status: COMPLETED 
Condition: Non-Hodgkin’s Lymphoma 

NCTID: NCT05079230

Title: Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia 
Study Summary: The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy. 
Sponsor: Gilead Sciences 
Intervention: Magrolimab 
Start Date: 2022-07-07 
Last Updated: 2023-10-30 
Number of Patients: 432 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT00932451

Title: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene 
Study Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066. 
Sponsor: Pfizer 
Intervention: PF-02341066 
Start Date: 2010-01 
Last Updated: 2017-01-13 
Number of Patients: 1069 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT05076942

Title: Groningen International Study on Sentinel Nodes in Vulvar Cancer-III 
Study Summary: Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy. 
Sponsor: University Medical Center Groningen 
Intervention: Radiotherapy combined with cisplatin 
Start Date: 2021-01-01 
Last Updated: 2023-08-01 
Number of Patients: 157 
Recruitment Status: RECRUITING 
Condition: Vulvar Cancer 

NCTID: NCT05153330

Title: Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL 
Study Summary: A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL. 
Sponsor: Biomea Fusion Inc. 
Intervention: BMF-219 
Start Date: 2022-01-24 
Last Updated: 2023-10-06 
Number of Patients: 177 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT02450331

Title: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection 
Study Summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2015-10-05 
Last Updated: 2023-06-18 
Number of Patients: 809 
Recruitment Status: TERMINATED 
Condition: Carcinoma, Transitional Cell 

NCTID: NCT00005585

Title: Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for childhood acute lymphoblastic leukemia.  PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: cyclophosphamide 
Start Date: 2000-04 
Last Updated: 2023-04-06 
Number of Patients: 838 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT03391466

Title: Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma 
Study Summary: The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). 
Sponsor: Kite, A Gilead Company 
Intervention: Axicabtagene Ciloleucel 
Start Date: 2018-01-25 
Last Updated: 2023-07-06 
Number of Patients: 359 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) 

NCTID: NCT00003625

Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.  PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma. 
Sponsor: Children’s Oncology Group 
Intervention: cyclosporine 
Start Date: 1998-12 
Last Updated: 2014-07-28 
Number of Patients: 7 
Recruitment Status: COMPLETED 
Condition: Brain Tumors 

NCTID: NCT00027846

Title: Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma 
Study Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.  PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 2003-08 
Last Updated: 2019-08-07 
Number of Patients: 378 
Recruitment Status: COMPLETED 
Condition: Brain Tumor 

NCTID: NCT01909453

Title: Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma 
Study Summary: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.  Part 1:  Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:  # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm)  Part 2:  Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:  # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) 
Sponsor: Pfizer 
Intervention: LGX818 
Start Date: 2013-12-13 
Last Updated: 2023-09-07 
Number of Patients: 921 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma 

NCTID: NCT01189253

Title: Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma.  PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: doxorubicin hydrochloride 
Start Date: 2011-05 
Last Updated: 2014-08-08 
Number of Patients: 133 
Recruitment Status: TERMINATED 
Condition: Sarcoma 

NCTID: NCT00003573

Title: Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.  PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 1998-11 
Last Updated: 2014-07-25 
Number of Patients: 53 
Recruitment Status: COMPLETED 
Condition: Brain Tumors 

NCTID: NCT00005977

Title: Combination Chemotherapy in Treating Patients With Non-Hodgkin’s Lymphoma or Acute Lymphocytic Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin’s lymphoma or acute lymphocytic leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 2000-09 
Last Updated: 2013-08-21 
Number of Patients: 83 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT03731260

Title: (PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis 
Study Summary: This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group. 
Sponsor: Blueprint Medicines Corporation 
Intervention: Avapritinib 
Start Date: 2019-04-16 
Last Updated: 2023-06-15 
Number of Patients: 251 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Indolent Systemic Mastocytosis 

NCTID: NCT03486873

Title: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) 
Study Summary: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.  This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.  Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-08-21 
Last Updated: 2023-11-27 
Number of Patients: 2300 
Recruitment Status: RECRUITING 
Condition: Solid Tumors 

NCTID: NCT02598661

Title: Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study.  An Extension Phase has been included to allow continued treatment for those subjects who are benefitting from imetelstat and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment. 
Sponsor: Geron Corporation 
Intervention: Imetelstat 
Start Date: 2015-11-24 
Last Updated: 2023-11-18 
Number of Patients: 289 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Myelodysplastic Syndromes 

NCTID: NCT00028795

Title: Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.  PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma. 
Sponsor: Children’s Oncology Group 
Intervention: temozolomide 
Start Date: 2002-12 
Last Updated: 2014-02-21 
Number of Patients: 170 
Recruitment Status: COMPLETED 
Condition: Brain and Central Nervous System Tumors 

NCTID: NCT03374488

Title: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma 
Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease. 
Sponsor: Incyte Corporation 
Intervention: Pembrolizumab 
Start Date: 2017-12-22 
Last Updated: 2021-11-30 
Number of Patients: 84 
Recruitment Status: COMPLETED 
Condition: UC (Urothelial Cancer) 

NCTID: NCT03345095

Title: A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma 
Study Summary: The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT –>TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT –>TMZ, a phase III study is considered essential to establishing its impact on overall survival. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Marizomib 
Start Date: 2018-07-26 
Last Updated: 2023-05-24 
Number of Patients: 749 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Newly Diagnosed Glioblastoma 

NCTID: NCT00002995

Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma 
Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.  PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma. 
Sponsor: Children’s Oncology Group 
Intervention: dactinomycin 
Start Date: 1997-08 
Last Updated: 2014-02-14 
Number of Patients: 483 
Recruitment Status: COMPLETED 
Condition: Sarcoma 

NCTID: NCT00002594

Title: Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so that they stop growing or die. bone marrow transplantation and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors. 
Sponsor: Children’s Oncology Group 
Intervention: Sargramostim 
Start Date: 1994-09 
Last Updated: 2014-07-24 
Number of Patients: 31 
Recruitment Status: COMPLETED 
Condition: Brain Tumor 

NCTID: NCT00002610

Title: Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors.  PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors. 
Sponsor: Children’s Oncology Group 
Intervention: dactinomycin 
Start Date: 1996-01 
Last Updated: 2014-07-25 
Number of Patients: 203 
Recruitment Status: COMPLETED 
Condition: Kidney Cancer 

NCTID: NCT00003955

Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma. 
Sponsor: Children’s Oncology Group 
Intervention: dactinomycin 
Start Date: 1999-09 
Last Updated: 2014-02-14 
Number of Patients: 77 
Recruitment Status: COMPLETED 
Condition: Sarcoma 

NCTID: NCT03061812

Title: Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) 
Study Summary: The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy. 
Sponsor: AbbVie 
Intervention: Rovalpituzumab tesirine 
Start Date: 2017-04-11 
Last Updated: 2021-02-23 
Number of Patients: 444 
Recruitment Status: COMPLETED 
Condition: Small Cell Lung Cancer 

NCTID: NCT00887146

Title: Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma 
Study Summary: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma. 
Sponsor: Alliance for Clinical Trials in Oncology 
Intervention: concomitant temozolomide (TMZ) 
Start Date: 2009-09 
Last Updated: 2023-11-01 
Number of Patients: 360 
Recruitment Status: RECRUITING 
Condition: Brain and Central Nervous System Tumors 

NCTID: NCT04222972

Title: A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) 
Study Summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib. 
Sponsor: Hoffmann-La Roche 
Intervention: Pralsetinib 
Start Date: 2020-07-24 
Last Updated: 2023-11-13 
Number of Patients: 226 
Recruitment Status: RECRUITING 
Condition: RET-fusion Non Small Cell Lung Cancer 

NCTID: NCT04358458

Title: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas 
Study Summary: The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009. GEN3009 will be studied in a broad group of cancer patients, having different kinds of lymphomas. All patients will get GEN3009 either as a single treatment (monotherapy) or in combination with another antibody-candidate for treatment of cancer in the blood. The study consists of two parts: Part 1 tests increasing doses of GEN3009 (“escalation”), followed by Part 2 which tests the recommended GEN3009 dose from Part 1 (“expansion”). 
Sponsor: Genmab 
Intervention: GEN3009 
Start Date: 2020-03-24 
Last Updated: 2023-09-21 
Number of Patients: 46 
Recruitment Status: TERMINATED 
Condition: Diffuse Large B-cell Lymphoma 

NCTID: NCT02580058

Title: A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) 
Study Summary: A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer. 
Sponsor: Pfizer 
Intervention: avelumab 
Start Date: 2015-12-21 
Last Updated: 2023-07-10 
Number of Patients: 566 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT00005596

Title: Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of chemotherapy is more effective for acute lymphoblastic leukemia.  PURPOSE: This randomized phase III trial is comparing four regimens of combination chemotherapy to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: cyclophosphamide 
Start Date: 2000-04 
Last Updated: 2023-04-06 
Number of Patients: 1076 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT05361395

Title: First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC) 
Study Summary: This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy. 
Sponsor: Amgen 
Intervention: Tarlatamab 
Start Date: 2022-08-24 
Last Updated: 2023-11-09 
Number of Patients: 340 
Recruitment Status: RECRUITING 
Condition: Extensive Stage Small Cell Lung Cancer 

NCTID: NCT00056069

Title: Study of the Physical and Emotional Needs of Parents Caring for Children Receiving Chemotherapy for Acute Lymphoblastic Leukemia 
Study Summary: RATIONALE: Studying the physical and emotional needs of parents who are caring for children receiving chemotherapy for cancer may help doctors plan effective treatments for the patient that allow for improved quality of life of the patient’s family.  PURPOSE: This clinical trial is studying the different physical and emotional needs of parents whose children are undergoing chemotherapy for acute lymphoblastic leukemia either in an outpatient clinic or in the hospital. 
Sponsor: Children’s Oncology Group 
Intervention: questionnaire administration 
Start Date: 2002-12 
Last Updated: 2015-05-07 
Number of Patients: 172 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT00003935

Title: Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy may kill more tumor cells.  PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma. 
Sponsor: Children’s Oncology Group 
Intervention: etoposide 
Start Date: 1999-09 
Last Updated: 2014-07-28 
Number of Patients: 31 
Recruitment Status: COMPLETED 
Condition: Brain Tumors 

NCTID: NCT00865969

Title: Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma 
Study Summary: The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy. 
Sponsor: Spectrum Pharmaceuticals, Inc 
Intervention: Belinostat 
Start Date: 2008-12-15 
Last Updated: 2021-10-29 
Number of Patients: 129 
Recruitment Status: COMPLETED 
Condition: Peripheral T-cell Lymphoma 

NCTID: NCT01734928

Title: Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone. 
Sponsor: Celgene 
Intervention: Pomalidomide 
Start Date: 2013-01-07 
Last Updated: 2023-06-06 
Number of Patients: 559 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT02088541

Title: Selinexor (KPT-330) in Older Patients With Relapsed AML 
Study Summary: This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy. 
Sponsor: Karyopharm Therapeutics Inc 
Intervention: Selinexor 
Start Date: 2014-03 
Last Updated: 2023-01-26 
Number of Patients: 317 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia (AML) 

NCTID: NCT01510184

Title: Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy. 
Sponsor: Spectrum Pharmaceuticals, Inc 
Intervention: Zevalin 
Start Date: 2012-04-19 
Last Updated: 2021-12-16 
Number of Patients: 79 
Recruitment Status: TERMINATED 
Condition: Diffuse Large B-cell Lymphoma 

NCTID: NCT00904241

Title: Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma 
Study Summary: This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. 
Sponsor: Children’s Oncology Group 
Intervention: Cytology Specimen Collection Procedure 
Start Date: 2000-11-06 
Last Updated: 2023-04-13 
Number of Patients: 10000 
Recruitment Status: RECRUITING 
Condition: Ganglioneuroblastoma 

NCTID: NCT00006102

Title: Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin’s Lymphoma 
Study Summary: Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin’s lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. 
Sponsor: National Cancer Institute (NCI) 
Intervention: becatecarin 
Start Date: 2000-07 
Last Updated: 2013-02-05 
Number of Patients: 200 
Recruitment Status: COMPLETED 
Condition: Brain and Central Nervous System Tumors 

NCTID: NCT00004932

Title: STI571 in Treating Patients With Recurrent Leukemia 
Study Summary: RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia.  PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: imatinib mesylate 
Start Date: 2002-01 
Last Updated: 2014-02-21 
Number of Patients: 31 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT00021242

Title: Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die.  PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: docetaxel 
Start Date: 2002-08 
Last Updated: 2014-08-08 
Number of Patients: 12 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT05239728

Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) 
Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.  The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Belzutifan 
Start Date: 2022-03-15 
Last Updated: 2023-11-28 
Number of Patients: 1800 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT00003178

Title: Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.  PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 1998-03 
Last Updated: 2014-07-25 
Number of Patients: 120 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT02714218

Title: A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma 
Study Summary: The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma. 
Sponsor: Bristol-Myers Squibb 
Intervention: Nivolumab 3 mg/kg IV 
Start Date: 2016-04-04 
Last Updated: 2022-06-24 
Number of Patients: 387 
Recruitment Status: COMPLETED 
Condition: Melanoma 

NCTID: NCT02031458

Title: A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer 
Study Summary: This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2014-01-22 
Last Updated: 2020-01-06 
Number of Patients: 667 
Recruitment Status: COMPLETED 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT00005584

Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin’s Lymphoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin’s lymphoma.  PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin’s lymphoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: bleomycin sulfate 
Start Date: 1998-10 
Last Updated: 2023-02-15 
Number of Patients: 1649 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Lymphoma 

NCTID: NCT03673501

Title: A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib 
Study Summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off). 
Sponsor: Deciphera Pharmaceuticals LLC 
Intervention: DCC-2618 
Start Date: 2019-02-11 
Last Updated: 2021-01-06 
Number of Patients: 426 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Gastrointestinal Stromal Tumors 

NCTID: NCT00009698

Title: Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia 
Study Summary: RATIONALE: Interleukin-2 may stimulate a person’s white blood cells to kill more cancer cells.  PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia. 
Sponsor: Children’s Oncology Group 
Intervention: aldesleukin 
Start Date: 1998-03 
Last Updated: 2013-06-28 
Number of Patients: 1 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT04472598

Title: Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis 
Study Summary: Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body’s normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.  Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide.  Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug.  There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires. 
Sponsor: AbbVie 
Intervention: Navitoclax 
Start Date: 2020-09-29 
Last Updated: 2023-04-27 
Number of Patients: 252 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Myelofibrosis (MF) 

NCTID: NCT00002944

Title: Combination Chemotherapy in Treating Children With Progressive Brain Tumors 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.  PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain. 
Sponsor: Children’s Oncology Group 
Intervention: carboplatin 
Start Date: 1997-04 
Last Updated: 2013-09-09 
Number of Patients: 428 
Recruitment Status: COMPLETED 
Condition: Brain Tumors 

NCTID: NCT02322281

Title: TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy 
Study Summary: The purpose of this study is to compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the PFS, with that of single-agent cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet chemotherapy. 
Sponsor: Clovis Oncology, Inc. 
Intervention: Rociletinib 
Start Date: 2015-02 
Last Updated: 2019-08-14 
Number of Patients: 149 
Recruitment Status: TERMINATED 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT04143711

Title: Study of DF1001 in Patients With Advanced Solid Tumors 
Study Summary: DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab paclitaxel. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2. 
Sponsor: Dragonfly Therapeutics 
Intervention: DF1001 
Start Date: 2019-11-11 
Last Updated: 2022-12-06 
Number of Patients: 490 
Recruitment Status: RECRUITING 
Condition: Solid Tumor, Adult 

NCTID: NCT00003811

Title: Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors 
Study Summary: RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.  PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors. 
Sponsor: Children’s Oncology Group 
Intervention: bleomycin sulfate 
Start Date: 2000-04 
Last Updated: 2013-07-04 
Number of Patients: 27 
Recruitment Status: COMPLETED 
Condition: Childhood Germ Cell Tumor 

NCTID: NCT00002611

Title: Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer.  PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer. 
Sponsor: Children’s Oncology Group 
Intervention: dactinomycin 
Start Date: 1995-07 
Last Updated: 2021-02-25 
Number of Patients: 3031 
Recruitment Status: COMPLETED 
Condition: Kidney Cancer 

NCTID: NCT00003234

Title: Vinorelbine in Treating Children With Recurrent or Refractory Cancers 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.  PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer. 
Sponsor: Children’s Oncology Group 
Intervention: vinorelbine tartrate 
Start Date: 1998-05 
Last Updated: 2014-07-28 
Number of Patients: 50 
Recruitment Status: COMPLETED 
Condition: Brain and Central Nervous System Tumors 

NCTID: NCT02737501

Title: ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants 
Study Summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS). 
Sponsor: Ariad Pharmaceuticals 
Intervention: Brigatinib 
Start Date: 2016-05-26 
Last Updated: 2021-08-20 
Number of Patients: 275 
Recruitment Status: COMPLETED 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT00006734

Title: Comparison of Combination Chemotherapy Regimens in Treating Patients With Ewing’s Sarcoma or Neuroectodermal Tumor 
Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which chemotherapy regimen combined with radiation therapy and/or surgery is more effective in treating Ewing’s sarcoma or primitive neuroectodermal tumor.  PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens combined with radiation therapy and/or surgery in treating patients who have Ewing’s sarcoma or primitive neuroectodermal tumor. 
Sponsor: Children’s Oncology Group 
Intervention: filgrastim 
Start Date: 2001-05 
Last Updated: 2023-08-03 
Number of Patients: 587 
Recruitment Status: COMPLETED 
Condition: Sarcoma 

NCTID: NCT04303780

Title: Study to Compare AMG 510 “Proposed INN Sotorasib” With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). 
Study Summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation 
Sponsor: Amgen 
Intervention: AMG 510 
Start Date: 2020-06-04 
Last Updated: 2023-10-23 
Number of Patients: 345 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC 

NCTID: NCT01849874

Title: A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer 
Study Summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician’s choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study. 
Sponsor: Pfizer 
Intervention: MEK162, MEK inhibitor; oral 
Start Date: 2013-06-27 
Last Updated: 2023-10-30 
Number of Patients: 341 
Recruitment Status: TERMINATED 
Condition: Low-grade Serous Ovarian Cancer 

NCTID: NCT00006024

Title: Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.  PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma. 
Sponsor: Children’s Oncology Group 
Intervention: lomustine 
Start Date: 2000-11 
Last Updated: 2014-02-13 
Number of Patients: 32 
Recruitment Status: COMPLETED 
Condition: Brain Tumor 

NCTID: NCT04623541

Title: Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome 
Study Summary: The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as:  * Monotherapy, or * Combination therapy: ** epcoritamab + venetoclax ** epcoritamab + lenalidomide ** epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone).  The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter’s Syndrome (RS).  Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase. 
Sponsor: Genmab 
Intervention: Epcoritamab 
Start Date: 2020-11-25 
Last Updated: 2023-11-15 
Number of Patients: 184 
Recruitment Status: RECRUITING 
Condition: Relapsed/Refractory Chronic Lymphocytic Leukemia 

NCTID: NCT00002941

Title: Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin’s or Non-Hodgkin’s Lymphoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells.  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have recurrent or refractory Hodgkin’s lymphoma or non-Hodgkin’s lymphoma. 
Sponsor: Children’s Oncology Group 
Intervention: carmustine 
Start Date: 1998-04 
Last Updated: 2014-08-01 
Number of Patients: 69 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT03748641

Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer 
Study Summary: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Niraparib 
Start Date: 2019-01-25 
Last Updated: 2023-11-13 
Number of Patients: 765 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Castration-Resistant Prostatic Cancer 

NCTID: NCT05605899

Title: Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma 
Study Summary: The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma. 
Sponsor: Kite, A Gilead Company 
Intervention: Axicabtagene Ciloleucel 
Start Date: 2023-02-10 
Last Updated: 2023-11-18 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: High-risk Large B-cell Lymphoma (LBCL) 

NCTID: NCT05382299

Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer 
Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician’s choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1. 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab Govitecan-hziy 
Start Date: 2022-07-20 
Last Updated: 2023-11-15 
Number of Patients: 540 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer 

NCTID: NCT03616470

Title: Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia 
Study Summary: This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML 
Sponsor: GlycoMimetics Incorporated 
Intervention: Uproleselan 
Start Date: 2018-10-15 
Last Updated: 2023-07-25 
Number of Patients: 388 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT01801111

Title: A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment 
Study Summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib. 
Sponsor: Hoffmann-La Roche 
Intervention: Erlotinib 
Start Date: 2013-06-20 
Last Updated: 2018-11-02 
Number of Patients: 138 
Recruitment Status: COMPLETED 
Condition: Non-Small-Cell Lung Carcinoma 

NCTID: NCT02631070

Title: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes 
Study Summary: The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.  This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. 
Sponsor: Celgene 
Intervention: Luspatercept 
Start Date: 2016-02-09 
Last Updated: 2021-12-17 
Number of Patients: 229 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT04313881

Title: Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) 
Study Summary: The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS). 
Sponsor: Gilead Sciences 
Intervention: Magrolimab 
Start Date: 2020-09-09 
Last Updated: 2023-09-25 
Number of Patients: 539 
Recruitment Status: TERMINATED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT02678299

Title: Phase 1/2 Study of the Combination of Pixantrone, Etoposide, Bendamustine and, in CD20 Positive Tumors, Rituximab in Patients With Relapsed Aggressive Non-Hodgkin Lymphomas of B- or T-cell Phenotype - the P[R]EBEN Study 
Study Summary: This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with bendamustine, etoposide and , for CD20 positive B-cell lymphomas, rituximab (P<math display="block">R</math>EBEN), in patients with relapsed aNHL of B- or T-cell phenotype. 
Sponsor: University of Aarhus 
Intervention: PREBEN 
Start Date: 2016-02 
Last Updated: 2022-08-04 
Number of Patients: 60 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Malignant Lymphoma