Editing 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