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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…

A phase II, single arm, multicenter study of nilotinib in combination with pegylated interferon *2b in patients with suboptimal molecular response or stable detectable molecular residual disease after at least two years of imatinib treatment (NordDutchCML009)

To assess the effect of switching CML patients, who have been treated with imatinib *2 years and who have stable detectable molecular residual disease above 0.01% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of…

A Phase 2, Multicenter, Single-arm Study of Moxetumomab Pasudotox in Pediatric Subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin

The primary objective is:Assess the efficacy defined as Composite Complete Response (CRc)The secondary objectives of this study are:* Assess safety and tolerability* Assess immunogenicity and pharmacokinetics* Progression-free survival (PFS),…

The feasibility and efficacy of subcutaneous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA*identical sibling donors: a prospective phase II study.

Primary objectiveTo determine the feasibility of plerixafor 320 *g/kg subcutaneously to harvest a sufficient number of CD34+ peripheral blood stem cells/kg recipient body weight. Feasibilty is defined as a minimum of 2.0x10^6/kg CD34+ cells in one…

Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality risk

Primary objectives:• To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >=1.5) with a high risk of…

A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors

This study has been transitioned to CTIS with ID 2024-513412-10-00 check the CTIS register for the current data. Phase 1: • To determine the MTD/RP2D regimen of brigatinib monotherapy when administered in pediatric and AYA patients with ALK+ ALCL or…

A phase I/II feasibility study of panobinostat alone and the combination of panobinostat and decitabine prior to donor lymphocyte infusion in recipients of allogeneic stem cell transplantation with poor and very poor risk AML

Primary objective:Part I- To asses the feasibility of addition of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT in patients with very poor risk AML/RAEB, and select the dose level for the phase II…

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 I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF IDASANUTLIN IN COMBINATION WITH EITHER CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID TUMORS.

This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…

A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety,
Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib
Administered in Combination with Re-Induction Chemotherapy, and as a
Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML
Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years)
with FLT3-ITD mutations

This study has been transitioned to CTIS with ID 2023-510009-16-00 check the CTIS register for the current data. Primary Objectives:• Phase 1 Only: To determine the recommended Phase 2 dose(RP2D) of quizartinib, in combination with chemotherapy,…

International multicenter, open-label, phase 2 study to treat molecular relapse of pediatric acute myeloid leukemia with azacitidine

• Primary Objective: To evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after CR1 with regard to molecular response prior to further treatment (reinduction / HSCT)• Secondary Objectives:o To assess safety of…

Matched Unrelated vs. Haploidentical donor for allogeneic stem cell transplantation in patients with Acute Leukemia with identical GVHD prophylaxis - A randomized porspective European trial.

Primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anit-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 HLA…

An international, multicentre, open-label study to evaluate the efficacy and safety of two different vaccination regimens of immunotherapy with allogeneic dendritic cells, DCP-001, in patients with acute myeloid leukemia that are in remission with persistent MRD.

Primary:• To assess the effect of DCP-001 on MRD. MRD will be measured by flow cytometry pre and post vaccination as a surrogate marker for established clinical endpoints in AML.• To assess the effect of DCP-001 on immune responses in AML patients…

First line treatment with VeNEtoclaX and ibruTinib induction followed by obinutuzumab intenSificaTion Exclusively in CLL/SLL Patients not in complete remission and/or with detectable bone marrow minimal residual disease (NEXT STEP trial)

Primary objective- To evaluate the efficacy of 6 cycles ibrutinib/obinutuzumab in converting patients who are not in CR or who have detectable MRD on combination ibrutinib and venetoclax in uMRD (BM) CR Secondary objectives- To explore the kinetics…

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (ESMART)

This study has been transitioned to CTIS with ID 2024-514791-40-00 check the CTIS register for the current data. Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed…

REtreatment with VEnetoclax and Acalabrutinib after venetoclax Limited duration (REVEAL)
A prospective, multicenter, phase-II trial of venetoclax plus acalabrutinib in patients who have relapsed after first line venetoclax + anti-CD20 mAb treatment for chronic lymphocytic leukemia (CLL or SLL)

This study has been transitioned to CTIS with ID 2023-505449-18-00 check the CTIS register for the current data. Primary objective• To evaluate efficacy of acalabrutinib/venetoclax (AV) in terms of undetectable minimal residual disease (uMRD)…

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…

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants.

This study has been transitioned to CTIS with ID 2023-509699-41-00 check the CTIS register for the current data. Primary objectives:Phase 1: To determine the MTD and/or RP2D of oral ponatinib administered QD in pediatric participants with selected…

A multi-center, open-label study to determine the dose and safety of oral asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors.

This study has been transitioned to CTIS with ID 2023-508129-28-00 check the CTIS register for the current data. The primary objective of this study is to characterize the pharmacokinetic (PK) profile of asciminib in pediatric patients, with the…