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A Randomized, Multi-Center Phase III Trial comparing two conditioning regimens (CloFluBu and BuCyMel) in children with Acute Myeloid Leukemia undergoing allogeneic stem cell transplantation.

This study has been transitioned to CTIS with ID 2023-505512-37-00 check the CTIS register for the current data. The primary objective of the randomized part of the protocol is to investigate if a conditioning regimen containing one alkylator (Bu)…

A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Primary Objective:• To evaluate event-free survival (EFS) after blinatumomab when compared to standard ofcare (SOC) chemotherapySecondary Objective(s):• To evaluate the effect of blinatumomab on overall survival (OS) when compared to SOCchemotherapy…

A Phase 1/2, open label, multicenter study to assess the safety and tolerability of durvalumab (anti-PD-L1 antibody) as monotherapy and in combination therapy in subjects with lymphoma or chronic lymphocytic leukemia. (MEDI4736-NHL-001). The *FUSION NHL 001* Study.

PRIMARY: Dose finding part (Phase 1):To assess the safety and tolerability of durvalumab when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab to determine the recommended Phase 2 doses (RP2Ds) of each…

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

This study has been transitioned to CTIS with ID 2023-503640-14-00 check the CTIS register for the current data. Primary:• To compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy to EFS of…

A prospective, multicenter, phase-II trial of ibrutinib plus venetoclax in physically fit patients with creatinine clearance >= 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL) with or without TP53 aberrations;HOVON 141 CLL / VIsion Trial of the HOVON and Nordic CLL study groups

This study has been transitioned to CTIS with ID 2023-510557-42-00 check the CTIS register for the current data. The primary objective: - Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for…

SUSTRENIM - GIMEMA CML1415 / HOVON 142 CML

This study has been transitioned to CTIS with ID 2023-510434-83-00 check the CTIS register for the current data. The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in…

A phase 1/2a, first-in-human, open-label, multicenter, dose escalation study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

This study has been transitioned to CTIS with ID 2023-505259-39-00 check the CTIS register for the current data. Primary objectives: • Determine the safety and tolerability • Define the recommended phase 2 dose regimen (RP2D-R) and/or the maximum…

A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T cells (WU-CART-007) in Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

Primary Objectives• To characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) and define the Recommended Phase 2 Dose (RP2D) of WU-CART-007 in…

A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA

This study has been transitioned to CTIS with ID 2023-509810-13-00 check the CTIS register for the current data. Primary Objectives Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction in paediatric participants between 1…

Quality of life, Survival, COmorbidities, and Pharmacoeconomics in Elderly patients with Acute Myeloid Leukemia

We aim to measure quality of life and overall survival in patients with AML classified as ineligible for intensive chemotherapy and get treated with HMA combination regimens in the Medical Centre Leeuwarden. We also aim to determine the predictive…

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

This study has been transitioned to CTIS with ID 2023-506945-42-00 check the CTIS register for the current data. Primary* Evaluate the safety and tolerability of SEA-CD70* Identify the maximum tolerated dose (MTD) or recommended expansion dose of…

A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax
in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic
Syndrome (Higher-Risk MDS)

This study has been transitioned to CTIS with ID 2023-507153-16-00 check the CTIS register for the current data. To assess the efficacy of venetoclax in combination with AZA compared to placebo with AZA in treatment-naive higher-risk MDS.

A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302)

This study has been transitioned to CTIS with ID 2024-510947-71-00 check the CTIS register for the current data. Primary:To assess the tolerability of asciminib versus nilotinib with respect to the time to discontinuation of study treatment due to…

An alternating panel, single ascending dose trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, relative bioavailability, and food effect of orally administered AS-1763 in healthy subjects

In this study we will investigate how safe the new compound AS-1763 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent AS-1763 is absorbed, transported, and eliminated from the…

An open-label study to investigate the effects of emvododstat on the pharmacokinetics of CYP2D6 and BCRP substrates in healthy volunteers

In this study, we will investigate what the effect of the new compound emvododstat is on how quickly and to what extent 2 approved medications (dextromethorphan in Part 1 and rosuvastatin in Part 2) are absorbed, transported, and eliminated from the…

An Open Label Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects with Previously-Treated Solid Tumors and Hematologic Malignancies

The primary objectives are to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ABBV-621 and to evaluate pharmacokinetics (PK) of (A) single agent ABBV-621; and (B) the combination of ABBV-621 and venetoclax in…

Methionin-low diet in acute leukemia patients, a phase I pilot

Safety of a methionine-low diet in patients with AML

International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - A randomized Phase II Study Conducted by the Resistant Disease Committee of the International BFM Study Group.

This study has been transitioned to CTIS with ID 2024-513070-21-00 check the CTIS register for the current data. Primary objectives: Improvement of CR2 rates after induction with ALL R3 with bortezomib versus withoutbortezomib in HR relapsed ALL…

A phase Ib feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with FLT3-ITD AML

Primary objective:To asses the safety and feasibility of post-transplant panobinostat combined with midostaurin in patients with adverse risk AML/RAEB with FLT3-ITD with high allelic ratio in terms of dose limiting toxicity.Secondary objectives:To…

Phase I, international, multicentre, open-label, non-randomised, non-comparative study of intravenously administered S64315, a Mcl1-inhibitor, in patients with Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)

The primary study objective is to determine the safety profile and tolerability of S64315 in patients with AML and MDS and to determine the recommended phase 2 dose. Secondly, the PK profile of S64315 and potential metabolites will be determined in…