Trials (Skåne University Hospital Cancer Centre)
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NCTID: NCT02730416
Title: Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer Study Summary: This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer. Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit Intervention: Nintedanib or Placebo; Carboplatin, Paclitaxel Start Date: 2016-12-12 Last Updated: 2023-09-21 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT03625037
Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma Study Summary: The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human (FIH)) * an expansion part (Phase 2a) * a dose-optimization part (Phase 2a) Sponsor: Genmab Intervention: Epcoritamab Start Date: 2018-06-26 Last Updated: 2023-08-08 Number of Patients: 786 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma (DLBCL)
NCTID: NCT00342316
Title: Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia Study Summary: This study compares overall survival between patients with acute myeloid leukemia, who are in complete remission following initial treatment with chemotherapy and whose remission is maintained either with a transplantation of stem cells obtained from a sibling or unrelated donor or with standard treatment, which is additional chemotherapy. The study hypothesis is that the group transplanted with stem cells from a donor will have a superior survival compared with patients treated with standard of care. Sponsor: Vastra Gotaland Region Intervention: Reduced Intensity Conditioning Stem Cell Transplantation Start Date: 2003-12-18 Last Updated: 2020-01-27 Number of Patients: 340 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT02562443
Title: Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA Study Summary: The study’s primary objective <math display="block">in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)</math>, is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk. Sponsor: Onconova Therapeutics, Inc. Intervention: rigosertib Start Date: 2015-12-02 Last Updated: 2022-09-26 Number of Patients: 372 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndrome
NCTID: NCT01928537
Title: Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine Study Summary: This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine. Sponsor: Onconova Therapeutics, Inc. Intervention: rigosertib sodium Start Date: 2013-08 Last Updated: 2020-06-30 Number of Patients: 67 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT03067051
Title: Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System Study Summary: The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer. Sponsor: SpectraCure AB Intervention: Verteporfin Start Date: 2017-03-21 Last Updated: 2023-04-27 Number of Patients: 66 Recruitment Status: RECRUITING Condition: Recurrent Prostate Cancer
NCTID: NCT04114825
Title: Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer Study Summary: This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V). Sponsor: RhoVac APS Intervention: RV001V Start Date: 2019-11-19 Last Updated: 2021-09-28 Number of Patients: 180 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer Recurrent
NCTID: NCT03293173
Title: Biomarker Driven Intensified ChemoImmunotherapy With Early CNS Prophylaxis Study Summary: This study is testing whether stratification of the patients according to biological risk factors for different treatment groups will improve the outcome of patients with clinically high diffuse large B-cell lymphoma (DLBCL). Sponsor: Nordic Lymphoma Group Intervention: R-CHOEP Start Date: 2017-08-04 Last Updated: 2020-03-04 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT03438396
Title: A Trial of Tisotumab Vedotin in Cervical Cancer Study Summary: A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2018-06-12 Last Updated: 2023-07-25 Number of Patients: 102 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT01303796
Title: A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia Study Summary: This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible. Sponsor: Cyclacel Pharmaceuticals, Inc. Intervention: Sapacitabine Start Date: 2011-10-01 Last Updated: 2022-06-22 Number of Patients: 482 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT04067180
Title: Randomized Clinical Study Assessing Haplo vs. URD in AML Study Summary: This study compares haplo-identical family donor stem cell transplantation (haplo SCT) to matched unrelated donor transplantation (URD SCT) in adult patients with acute myeloid leukemia (AML) with the hypothesis that haplo SCT is as good as URD SCT. Background: A haplo-identical family donor is a relative sharing 50% of the human leukocyte antigens (HLA) of the patient. SCT with this type of donor is increasing, and a number of retrospective studies have demonstrated its feasibility, but prospective randomized studies are still lacking. Such studies are necessary to establish the benefits of haplo SCT. For the ≈70% of the patients that lack the 1st choice donor, an HLA-matched sibling, the 2nd choice is an URD at most centers. However, if haplo-identical donors are as good as URDs, this could change. Haplo-identical donors have several advantages. Almost all patients have at least one available haplo-identical donor, while URDs can be difficult to find. It also eliminates the need for time-consuming donor searches, and is considerably less costly. The Study: Patients can be included in the study if they have AML and require SCT, ≥18 years, DO NOT have an HLA-matched sibling donor, and DO have potential haplo-identical family donors AND URDs. After enrollment in the study, the patients are assigned randomly to either haplo SCT or URD SCT. The treatment surrounding the transplantation differs according to the donor type. Patients receiving haplo-identical transplantation are treated with a specified chemotherapy protocol before transplantation and a chemotherapy combined with immunosuppressive drugs after the transplantation to prevent graft-vs. host disease (GVHD). The patients receiving URD SCT will be treated according to the standard protocol at their center. Thus, haplo SCT will be compared to what is currently used in patients without an HLA-identical sibling today. The primary endpoint of this study is graft-vs.-host disease- and relapse free survival two years after study inclusion. This measurement takes into account the side effect that causes the most long-term suffering, graft-vs-host disease, as well as leukemia relapse and thus indicates to what extent the treated patients remain relapse-free and without significant side effects. Secondary end points include relapse-free survival, frequencies of graft-versus-host disease and of infections, and the patients will be followed in the study for five years. Sponsor: Karolinska Institutet Intervention: allogeneic stem cell transplantation with a haplo-identical family donor graft Start Date: 2019-11-12 Last Updated: 2023-04-05 Number of Patients: 18 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT05020236
Title: MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Study Summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Part 3 of the study will evaluate an alternative dosing schedule of elranatamab in combination with daratumumab. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study. Sponsor: Pfizer Intervention: Elranatamab Start Date: 2021-10-04 Last Updated: 2023-08-24 Number of Patients: 854 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT05328258
Title: Use of GnRHa During Chemotherapy for Fertility Protection Study Summary: Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects. Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment. The patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. The injections may be given once monthly or once three months depending on type of chemotherapy given. Randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. The only person who knows is the nurse preparing the injection. Patients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires. Sponsor: Kenny Rodriguez-Wallberg Intervention: Triptorelin Embonate Start Date: 2023-03-31 Last Updated: 2023-10-27 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Breast Cancer Female
NCTID: NCT04307576
Title: A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia Study Summary: ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design. Sponsor: Mats Heyman Intervention: Omitted Doxorubicin Start Date: 2020-07-13 Last Updated: 2023-11-21 Number of Patients: 6430 Recruitment Status: RECRUITING Condition: Leukemia, Acute Lymphoblastic
NCTID: NCT04221035
Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Vincristine Start Date: 2019-11-05 Last Updated: 2023-02-13 Number of Patients: 800 Recruitment Status: RECRUITING Condition: High-Risk Neuroblastoma
NCTID: NCT02130557
Title: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia Study Summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. Sponsor: Pfizer Intervention: Bosutinib Start Date: 2014-07-15 Last Updated: 2021-05-18 Number of Patients: 536 Recruitment Status: COMPLETED Condition: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
NCTID: NCT03106324
Title: A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant Study Summary: This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months’ post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed. Sponsor: Celgene Intervention: Revlimid (lenalidomide) Start Date: 2017-03-31 Last Updated: 2022-06-02 Number of Patients: 911 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
