Trials (IRCCS Centro di Riferimento Oncologico della Basilicata): Difference between revisions

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Revision as of 13:59, 2 December 2025

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NCTID: NCT03268954

Title: Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) 
Study Summary: The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML). 
Sponsor: Takeda 
Intervention: Azacitidine 
Start Date: 2017-11-28 
Last Updated: 2023-09-05 
Number of Patients: 454 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Myelodysplastic Syndrome 

NCTID: NCT01074047

Title: Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) 
Study Summary: The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients. 
Sponsor: Celgene 
Intervention: Azacitidine 
Start Date: 2010-06-01 
Last Updated: 2017-08-29 
Number of Patients: 488 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT00482833

Title: Phase III Trial in Acute Promyelocytic Leukemia Patients 
Study Summary: Open label, randomised, phase III multicenter trial. 
Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto 
Intervention: arsenic trioxide 
Start Date: 2007-08 
Last Updated: 2022-10-12 
Number of Patients: 276 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT02063685

Title: Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma 
Study Summary: Recently, the availability of R has substantially changed therapeutic approach to FL patients, since its combination with chemotherapy has improved response rates, progression free survival (PFS) and overall survival (OS). Based on the results of recently completed randomized studies the standard treatment for patients with FL should consist of an initial therapy with R-CHOP combination followed by two-year maintenance with R. Although results of randomized trials confirmed that this approach results in an improved patients’ outcome and made a step forward in the management of patients with FL, one important question that can be raised is if this approach is really needed for all patients with FL or if some of them could benefit from a reduced intensity treatment achieving the same results in terms of outcome and survival . This question is of particular interest for newly diagnosed patients for whom maintenance does not affect OS.  More recent data demonstrated that the outcome of patients with FL can be further predicted by evaluating the quality of response to therapy studying minimal residual disease (MRD). This project addresses the objective of evaluating if combining clinical response assessed on FDG-PET scan and molecular response measured through MRD detection could permit to single out groups of patients at different risk of progression and to consequently modulate maintenance therapies, with the aim to provide clinicians a more rational use of the available diagnostic and therapeutic resources. 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: R-CHOP or R-bendamustine 
Start Date: 2012-07 
Last Updated: 2022-06-21 
Number of Patients: 807 
Recruitment Status: COMPLETED 
Condition: Follicular Non-Hodgkin’s Lymphoma 

NCTID: NCT02164903

Title: LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients 
Study Summary: The broad goal of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an additional objective is to characterize medication-taking behavior associated with imatinib or dasatinib. 
Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto 
Intervention: QoL Survey Booklet 
Start Date: 2014-09-11 
Last Updated: 2018-08-06 
Number of Patients: 323 
Recruitment Status: UNKNOWN 
Condition: Chronic Myeloid Leukemia 

NCTID: NCT02633189

Title: Study Comparing Bevacizumab + Erlotinib vs Erlotinib Alone as First Line Treatment of Patients With EGFR Mutated Advanced Non Squamous Non Small Cell Lung Cancer 
Study Summary: The purpose of this study is to test whether the combination of bevacizumab and erlotinib can prolong progression free survival as compared with erlotinib alone as first-line treatment in patients with non small cell lung cancer (NSCLC) with activating mutation of EGFR. 
Sponsor: National Cancer Institute, Naples 
Intervention: Erlotinib 
Start Date: 2016-04 
Last Updated: 2023-03-24 
Number of Patients: 200 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-squamous Non-small Cell Lung Cancer 

NCTID: NCT02348489

Title: SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction 
Study Summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy. 
Sponsor: Astex Pharmaceuticals, Inc. 
Intervention: SGI-110 (guadecitabine) 
Start Date: 2015-03-19 
Last Updated: 2021-01-14 
Number of Patients: 815 
Recruitment Status: COMPLETED 
Condition: Leukemia, Myeloid, Acute 

NCTID: NCT01640782

Title: Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach 
Study Summary: Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent and fulfilling all the inclusion/exclusion criteria are eligible for this study. 
Sponsor: Mario Negri Institute for Pharmacological Research 
Intervention: Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin 
Start Date: 2005-02 
Last Updated: 2014-07-18 
Number of Patients: 1100 
Recruitment Status: COMPLETED 
Condition: Adenocarcinoma of the Stomach 

NCTID: NCT03170882

Title: A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma 
Study Summary: The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines.  At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance.  * Ixazomib capsules, given with dexamethasone tablets * Pomalidomide capsules, given with dexamethasone tablets  All participants will take their study medicine on specific days during a 28-day cycle.  The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home.  After treatment, participants will visit the clinic every 12 weeks for a check-up.  If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures. 
Sponsor: Millennium Pharmaceuticals, Inc. 
Intervention: Ixazomib 
Start Date: 2017-08-01 
Last Updated: 2022-12-20 
Number of Patients: 122 
Recruitment Status: COMPLETED 
Condition: Relapsed and/or Refractory Multiple Myeloma 

NCTID: NCT01535391

Title: Nilotinib in PH+, BCR-, ABL+ CML Patients 
Study Summary: This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally twice daily for 24 months and indefinitely if it is in the interest of the patient.  The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice daily with dose increase to 400 mg twice daily in case of suboptimal response or failure (excluding patients who will fail for progression to ABP), in a population of patients with Ph-positive, BCR-ABL positive CML in early CP. 
Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto 
Intervention: Nilotinib 
Start Date: 2012-01 
Last Updated: 2018-08-06 
Number of Patients: 109 
Recruitment Status: COMPLETED 
Condition: Chronic Myeloid Leukemia 

NCTID: NCT01302106

Title: Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic Syndromes 
Study Summary: This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes. 
Sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS 
Intervention: Clofarabine plus low dose Ara-C 
Start Date: NA 
Last Updated: 2013-10-01 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Myelodysplastic Syndromes 

NCTID: NCT00999700

Title: Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin 
Study Summary: A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC). 
Sponsor: Gruppo Oncologico del Nord-Ovest 
Intervention: docetaxel - cisplatin - 5-fluorouracil 
Start Date: 2009-09 
Last Updated: 2017-09-05 
Number of Patients: 282 
Recruitment Status: UNKNOWN 
Condition: Squamous Cell Carcinoma of the Head and Neck 

NCTID: NCT03823625

Title: An Open-label, Randomized, Parallel, Non Comparative, Phase II Trial of Nivolumab Plus Ipilimumab Versus Platinum-based Chemotherapy Plus Nivolumab in Chemonaive Metastatic or Recurrent Squamous-Cell Lung Cancer (SqLC) 
Study Summary: Non-small-cell Lung Cancer (NSCLC) remains the leading cause of cancer death in Western Countries. Approximately 85% of lung cancers are of the non-small-cell type (NSCLC), with 25-30% of NSCLC being squamous histology type. Unlike nonsquamous NSCLC, squamous NSCLC rarely harbors epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations for which there are directed therapies, and until the recent approval of immunotherapies for pretreated squamous NSCLC, a limited number of traditional cytotoxic chemotherapy drugs have been FDA-approved for use in the treatment of advanced and metastatic squamous NSCLC. A platinum-based combination chemotherapy regimen has been the standard first-line treatment for all NSCLC. Carboplatin is frequently substituted for cisplatin for patients who have poor renal function or who experience toxicities from cisplatin (most notably, nausea and vomiting). Taxanes, especially paclitaxel, or vinorelbine or gemcitabine, commonly complete the standard two-drug backbone of platinum-based chemotherapy for the first-line treatment of NSCLC, with platin-gemcitabine as the most commonly used regimen in Europe in patients with squamous-histology. A recent press release announced that pembrolizumab plus chemotherapy produced higher response rate when compared to chemotherapy alone in patients with squamous-cell lung cancer. Nevertheless, no data on Progression-Free Survival (PFS) and Overall Survival (OS) are available. Therefore, considering the lack of data in patients with squamous histology and the lack of information about efficacy of combinations of immune-checkpoints inhibitors versus immune-checkpoint inhibitor plus chemotherapy, there is a strong rationale for conducting a study assessing efficacy of such strategies in patients with advanced, metastatic squamous-cell lung cancer. 
Sponsor: Fondazione Ricerca Traslazionale 
Intervention: Nivolumab plus Ipilimumab 
Start Date: 2017-09-13 
Last Updated: 2020-03-25 
Number of Patients: 112 
Recruitment Status: UNKNOWN 
Condition: Squamous-Cell Lung Cancer 

NCTID: NCT02371148

Title: Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s 
Study Summary: This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom’s Macroglobulinemia. 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: Bortezomib-Rituximab-Bendamustine 
Start Date: 2014-06 
Last Updated: 2020-12-02 
Number of Patients: 38 
Recruitment Status: COMPLETED 
Condition: Waldenstrom’s Macroglobulinemia 

NCTID: NCT04197986

Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations 
Study Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer. 
Sponsor: QED Therapeutics, Inc. 
Intervention: Infigratinib 
Start Date: 2020-03-11 
Last Updated: 2023-02-02 
Number of Patients: 39 
Recruitment Status: TERMINATED 
Condition: Upper Tract Urothelial Carcinomas 

NCTID: NCT01568866

Title: Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients 
Study Summary: The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone. 
Sponsor: Amgen 
Intervention: Carfilzomib 
Start Date: 2012-06-20 
Last Updated: 2022-11-14 
Number of Patients: 929 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT00979160

Title: Evaluation of Response of Dasatinib to Treat Mastocytosis 
Study Summary: This is a multicenter, open-label, single arm phase II non-randomized study of dasatinib in which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of dasatinib.  Upon completion of a treatment induction period, subjects will be treated with dasatinib at a dose of 100 mg per os (OS) once daily (QD). 
Sponsor: Federico II University 
Intervention: Dasatinib 
Start Date: 2009-11 
Last Updated: 2009-09-18 
Number of Patients: 30 
Recruitment Status: UNKNOWN 
Condition: Systemic Mastocytosis 

NCTID: NCT03568929

Title: Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma 
Study Summary: The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL). 
Sponsor: Gilead Sciences 
Intervention: Idelalisib 
Start Date: 2018-05-25 
Last Updated: 2021-11-19 
Number of Patients: 257 
Recruitment Status: COMPLETED 
Condition: Follicular Non-Hodgkin’s Lymphoma Refractory 

NCTID: NCT02904577

Title: Indolent Non Follicular Lymphomas Prognostic Project 
Study Summary: Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas. 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: Any treatment, watch and wait policy included 
Start Date: 2011-09 
Last Updated: 2023-09-14 
Number of Patients: 370 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Indolent B-Cell Lymphomas 

NCTID: NCT01951430

Title: Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients 
Study Summary: The purpose of this study is to observe the number of new cases of infections per population in a given time period and their characteristics in a pathology (myelodysplastic syndrome, MDS)that involves ineffective production (or dysplasia) of a class of blood cells. 
Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto 
Intervention: Antibiotic and antifungal drugs 
Start Date: 2014-03 
Last Updated: 2021-09-13 
Number of Patients: 229 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndrome 

NCTID: NCT01645124

Title: Large-scale Trial Testing the Intensity of CYTOreductive Therapy in Polycythemia Vera (PV) 
Study Summary: CYTO-PV is a phase III Prospective, Randomized, Open-label, with Blinded Endpoint evaluation (PROBE), multi-center, clinical trial in patients with diagnosis of Polycythemia vera (PV) treated at the best of recommended therapies (e.g.adequate control of standard cardiovascular risk factors). Irrespective of randomized interventions, all patients will be administered low-dose aspirin (when not contraindicated), i.e.the standard antithrombotic treatment in PV patients.  The purpose of this study to demonstrate that a more intensive cytoreductive therapy, plus low-dose aspirin when not contraindicated, with phlebotomy and/or hydroxyurea (HU), aimed at maintaining hematocrit (HCT) < 45% is more effective than a less intensive cytoreduction (either with phlebotomy or HU plus low-dose aspirin when not contraindicated) maintaining HCT in the range of 45-50% in the reduction of CV deaths plus thrombotic events (stroke, acute coronary syndrome <math display="block">ACS</math>, transient ischemic attack <math display="block">TIA</math>, pulmonary embolism <math display="block">PE</math>, splanchnic thrombosis, deep vein thrombosis <math display="block">DVT</math>, and any other clinically relevant thrombotic event), in patients with Polycythemia Vera treated at the best of recommended therapies (e.g. adequate control of standard cardiovascular risk factors). 
Sponsor: Consorzio Mario Negri Sud 
Intervention: Hydroxyurea 
Start Date: 2008-05 
Last Updated: 2012-07-20 
Number of Patients: 365 
Recruitment Status: TERMINATED 
Condition: Polycythemia Vera 

NCTID: NCT02394496

Title: Overcoming Endocrine Resistance in Metastatic Breast Cancer 
Study Summary: Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer. 
Sponsor: Consorzio Oncotech 
Intervention: Fulvestrant 
Start Date: 2007-11 
Last Updated: 2016-06-15 
Number of Patients: 396 
Recruitment Status: UNKNOWN 
Condition: Metastatic Breast Cancer 

NCTID: NCT04173494

Title: A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) 
Study Summary: MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US).  Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.  Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB.  Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF. 
Sponsor: Sierra Oncology LLC - a GSK company 
Intervention: Momelotinib 
Start Date: 2020-02-07 
Last Updated: 2023-11-01 
Number of Patients: 195 
Recruitment Status: COMPLETED 
Condition: Primary Myelofibrosis 

NCTID: NCT02491398

Title: Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia 
Study Summary: This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects. 
Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto 
Intervention: Bendamustine + Rituximab 
Start Date: 2016-02 
Last Updated: 2020-10-06 
Number of Patients: 494 
Recruitment Status: COMPLETED 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT01990144

Title: Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL 
Study Summary: The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA. 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: Bendamustine+Rituximab 
Start Date: 2011-11 
Last Updated: 2013-11-21 
Number of Patients: 49 
Recruitment Status: UNKNOWN 
Condition: Diffuse Large B-cell Lymphoma 

NCTID: NCT03441113

Title: Extended Access of Momelotinib in Adults With Myelofibrosis 
Study Summary: The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects. 
Sponsor: GlaxoSmithKline 
Intervention: MMB 
Start Date: 2018-05-03 
Last Updated: 2023-06-22 
Number of Patients: 237 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Neoplasms 

NCTID: NCT02181413

Title: A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant 
Study Summary: The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response <math display="block">CR</math>, very good partial response <math display="block">VGPR</math>, or partial response <math display="block">PR</math>) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT). 
Sponsor: Takeda 
Intervention: Ixazomib Citrate 
Start Date: 2014-07-01 
Last Updated: 2023-09-13 
Number of Patients: 656 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04811001

Title: Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations 
Study Summary: The best drug sequencing of dacomitinib or osimertinib in patients with advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation positive non-small-cell lung cancer (NSCLC) has not yet been determined. The study enables investigation of the efficacy of dacomitinib followed by or subsequent to osimertinib osimertinib in patients with classical or uncommon activating EGFR mutations. Efficacy of dacomitinib will be defined in patients with asymptomatic or controlled brain metastases, special population eligible in this clinical trial. 
Sponsor: Fondazione Ricerca Traslazionale 
Intervention: Osimertinib 
Start Date: 2020-06-12 
Last Updated: 2023-02-21 
Number of Patients: 170 
Recruitment Status: RECRUITING 
Condition: NSCLC 

NCTID: NCT01064557

Title: “AIDA” Protocol (LAP 0493) 
Study Summary: The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase. 
Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto 
Intervention: all-trans retinoic acid (ATRA) 
Start Date: 1993-10 
Last Updated: 2020-10-14 
Number of Patients: 1068 
Recruitment Status: UNKNOWN 
Condition: Leukemia