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International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia

This study has been transitioned to CTIS with ID 2022-502503-30-00 check the CTIS register for the current data. The primary objective is to improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2A…

A clinical study to investigate Interferon gamma (IFN*) signature in patients post HSCT and in patients with impaired HSC proliferation pre-transplant

HSCT cohort:* -To investigate the relationship between IFNγ levels and IFNγ activity by measuring CXCL9 levels and the risk of graft failure* -To investigate the relationship between IFNγ levels and IFNγ activity by measuring CXCL9 levels and the…

Monitor immune microenvironment and systemic immune effects in pediatric oncology

Brain tumors: Characterize and quantify changes in immune parameters during disease in patients with a CNS malignancyAML: Characterize and quantify changes in immune parameters and immunotherapeutic targets during disease in pediatric patients with…

A Phase 1 and 2a open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia

Primary Objective:Part 1 Dose Escalation• To investigate the safety and tolerability of LAVA-051 in patients with relapsed/refractory CLL, MM, or AML. • To determine the RP2D of LAVA-051 in patients with relapsed/refractory CLL, MM or AML.Part 2…

CHIP-AML22/Quizartinib: A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild type AML patients.
(A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium)

This study has been transitioned to CTIS with ID 2023-505000-27-01 check the CTIS register for the current data. To investigate the safety and efficacy of quizartinib in children and adolescents with newly diagnosed FLT3-ITD positive AML with normal…

A phase 1, multicenter, open-label, safety study of AG-120 or AG-221 in combination with induction therapy and consolidation therapy in patients with newly diagnosed acute myeloid leukemia with an IDH1 and/or IDH2 mutation

The primary objective of this study is to:• Determine the safety and tolerability of AG-120 and AG-221 when administered with induction and consolidation therapy in patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate…

International proof of concept therapeutic Stratification trial of Molecular Anomalies in Relapsed or Refractory HEMatological malignancies in children. Sub-Protocol D: Trametinib + Dexamethasone
+ Cyclophosphamide and Cytarabine in pediatric patients with relapsed or refractory hematological malignancies

This study has been transitioned to CTIS with ID 2022-501869-41-00 check the CTIS register for the current data. PrimaryPhase I: To assess the safety and tolerability of the investigational agents and define the MTD/RP2D(s)Phase II: To evaluate the…

A PHASE II OPEN-LABEL STUDY OF UM171-EXPANDED CORD BLOOD TRANSPLANTATION IN PATIENTS WITH HIGH AND VERY HIGH-RISK ACUTE LEUKEMIA/MYELODYSPLASIA.

This study has been transitioned to CTIS with ID 2024-517583-36-01 check the CTIS register for the current data. Primary:1) Examine the safety (including assessment of rate of graft failure) and feasibility of infusing a single ECT-001-expanded cord…

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

This study has been transitioned to CTIS with ID 2023-504828-25-00 check the CTIS register for the current data. Main objective Monotherapy Cohorts (R/R CLL):• Identify the RP2D and the MTD of epcoritamab• Evaluate the safety and tolerability of…

Multicenter, open-label, adaptive design phase I trial with genetically modified T-cells carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in combination with CD123 target module (TM123) for the treatment of patients with hematologic and lymphatic malignancies positive for CD123

This study has been transitioned to CTIS with ID 2024-515827-12-00 check the CTIS register for the current data. The primary objective of the phase 1a dose escalation was to assess the safety and to determine the maximum tolerated dose and the…

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B-cell Malignancies

This study has been transitioned to CTIS with ID 2024-511267-28-00 check the CTIS register for the current data. To evaluate the long-term safety of zanubrutinib in patients with B-cell cancers who participated in a BeiGene parent study for…

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…

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…

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

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…