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A randomized, multicenter, open-label, Phase 2 study with a safety run-in part to evaluate safety,
pharmacodynamics and efficacy of azacitidine compared to no anticancer treatment in children
and young adults with acute myeloid leukemia in molecular relapse after first complete
remission

Primary Objectives:Safety Run-in PartTo establish a safe and tolerable dose of azacitidine to be used in the randomized part of thestudy.Randomized PartTo evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after…

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >= 66 years .

Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of selinexor added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB >= 66 years and very poor risk AML >= 18 years

Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of Lenalidomide added to standard induction chemotherapy for AML and select the feasible dose level for part B of the study2. To assess in a randomized…

A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator*s choice of anti-leukemic treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1)

To investigate the efficacy, safety, and pharmacokinetics of volasertib in combination with low-dose cytarabine versus investigator*s choice of anti-leukemic treatment in patients with relapsed or refractory acute myeloid leukemia with no…

Bortezomib (Velcade®): A feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia

To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction therapy in AML and RAEB >= 66 years and very poor risk AML >= 18 years.;A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML

Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of tosedostat added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor

In this phase II study, the toxicity and treatment effects of early donor derived CD4+ lymphocyte infusion, three months after allo-SCT, will be evaluated

Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasie (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial)

This is a phase I/II trial of the EORTC Leukemia Group and the italian GIMEMA Acute Leukemia Working Party. In a phase I setting we will investigate the optimal dosage and route of administration (one hour infusion or intravenous injection) of…

A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years, HOVON 81

Evaluation of the safety and tolerability of Bevacizumab added to standard induction chemotherapy. Evaluation of the effect of Bevacizumab on the CR rate

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation

In this phase II study, the toxicity and treatment effects of early donor derived CD4+ lymphocyte infusion, three months after SCT, will be evaluated

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation

In this phase II study, the toxicity and treatment effects of early donor derived CD4+ lymphocyte infusion, three months after SCT, will be evaluated

Allogeneic hematopoietic cell transplantation with HLA-matched donors : a phase II randomized study comparing 2 nonmyeloablative conditionings

The present project aims at comparing two nonmyeloablative regimens currently used in 2 major HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy TBI with fludarabine (90…

A Randomized, open label, phase 2 study of the selective inhibitor of nuclear export (SINE) SELINEXOR (KPT-330) versus specified physician's choice in patients * 60 years old with relapsed/refractory acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy and/or transplantation.

Primary Objective:To determine overall survival (OS) of Selinexor as compared to physician choice (PC) in patients * 60 years old with relapsed/refractory AML that requires treatment and are ineligible for intensive chemotherapy and/or…

Short-term combined acalabrutinib and venetoclax treatment of newly diagnosed patients with CLL at high risk of infection and/or early treatment, who do not fulfil IWCLL treatment criteria for treatment. A randomized study with extensive immune phenotyping.

This study has been transitioned to CTIS with ID 2024-511072-33-00 check the CTIS register for the current data. The aim is thereby to reduce the risk of serious infections and the need for regular CLL treatment.

A PHASE 1B/2 OPEN-LABEL, RANDOMIZED STUDY OF 2 COMBINATIONS OF ISOCITRATE
DEHYDROGENASE (IDH) MUTANT TARGETED THERAPIES PLUS AZACITIDINE: ORAL AG-120 PLUS SUBCUTANEOUS AZACITIDINE AND ORAL AG-221 PLUS SC AZACITIDINE IN SUBJECTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA HARBORING AN IDH1 OR AN IDH2 MUTATION, RESPECTIVELY, WHO ARE NOT CANDIDATES TO RECEIVE INTENSIVE INDUCTION CHEMOTHERAPY

This study has been transitioned to CTIS with ID 2024-511722-31-00 check the CTIS register for the current data. Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when…

Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study (TARGET Study)

To address whether the individualized fludarabine conditioning reduces the incidence of severe viral infections at day 100 within the context of an αβTCR / CD19 depleted transplantation regimen.

A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) adult AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients.
A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT- AML/high-risk MDS patients.

This study has been transitioned to CTIS with ID 2023-503829-18-00 check the CTIS register for the current data. Primary objectives:- To assess in a randomized comparison the effect of midostaurin added to 10-day decitabine treatment on the…

A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of Gazyvaro (obinutuzumab) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens. (GIVE trial)

This study has been transitioned to CTIS with ID 2024-511048-22-00 check the CTIS register for the current data. -Primary objective- To separately study the efficacy, defined as MRD negative bone marrow and no progression according to the IWCLL…

A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged >= 66 years.
A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT-older AML/high-risk MDS patients

Primary objectives1. To assess in a randomized comparison the effect of Ibrutinib added to 10-day decitabine treatment on the cumulative CR/CRi rate after 3 cycles.Secondary objectives1. To assess the safety and tolerability of Ibrutinib added to 10…

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…