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Double blind placebo controlled randomized intervention study to validate the beneficial effect of hydrocortisone on dexamethasone-induced neurobehavioral side effects in pediatric acute lymphoblastic leukemia

The primary aim is to validate the finding that addition of physiological doses of hydrocortisone reduces dexamethasone-induced clinically relevant neurobehavioral problems. The secondary aims are to study the role of genetic variation, psychosocial…

Target attainment of ciprofloxacin as infection prophylaxis during chemotherapy-induced neutropenia in patients treated for haematological malignancies.

Prospectively investigate whether ciprofloxacin, administered as antibiotic prophylaxis in patients treated for haematological malignancies (with or without gastro-intestinal mucositis), in the currently recommended dosing regimen (500 mg orally or…

International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

This study has been transitioned to CTIS with ID 2024-515499-12-00 check the CTIS register for the current data. The primary objective is reducing treatment-related morbidity and mortality without adversely impacting DFS in Ph+ ALL patients,…

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…

A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy.

This study has been transitioned to CTIS with ID 2022-502832-37-00 check the CTIS register for the current data. To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy…

A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High-dose Therapy

This study has been transitioned to CTIS with ID 2023-506125-10-00 check the CTIS register for the current data. The primary objective is to determine if the addition of daratumumab to VRd will prolong PFS defined as the time from the date of…

A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This study has been transitioned to CTIS with ID 2023-503469-49-00 check the CTIS register for the current data. Primary ObjectiveThe primary objective of the study is to assess progression-free survival (PFS) from treatment with ibrutinib plus…

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.

European Intergroup Trial on panobinostat maintenance after HSCT for high-risk AML and MDS - A randomized, multicenter phase III study to assess the efficacy of panobinostat maintenance therapy vs. standard of care following allogeneic stem cell transplantation in patients with high-risk AML or MDS (ETAL-4 / HOVON-145)

Primary objective* To determine the efficacy of panobinostat maintenance therapy versus standard of care administered to patients with high-risk MDS or AML in complete hematologic remission after an allogeneic hematologic stem cell transplantation (…

Clinical aspects and molecular mechanisms in large granular lymphocyte (LGL) leukemia - IDeAL study

Overall objective of this IDeAL study is to unravel the biological heterogeneity of LGL leukemia and to correlate this with the clinical features. More specific objectives are: 1. Build a LGL leukemia registry (clinical features and lab data).2. Set…

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy (CCTL019G2201J)

This study has been transitioned to CTIS with ID 2023-508081-15-00 check the CTIS register for the current data. Primary: - To evaluate the efficacy of tisagenlecleucel therapy as measured by the overall survival (OS)- To evaluate the efficacy of…

A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy

This study has been transitioned to CTIS with ID 2022-502478-18-00 check the CTIS register for the current data. To compare OS between gilteritinib and midostaurin in combination with induction therapy and consolidation therapy followed by one-year…

A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric and young adult acute myeloid leukemia: the U-DANCE-anti-AML-trial

This study has been transitioned to CTIS with ID 2024-517922-24-00 check the CTIS register for the current data. Although DC vaccinations have been used in allo-HCT settings, no previous studies have been performed using a CBDC vaccine after CBT.…

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 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…

A Phase 1/2, open-label, single arm, multicohort, multicenter trial to evaluate the safety and efficacy of JCAR017 in pediatric subjects with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL) (TRANSCEND PEDALL)

Phase 1:To identify the recommended Phase 2 dose (RP2D) of JCAR017 in pediatric subjects withCD19+ r/r B-ALL.Phase 2:To evaluate the following efficacy endpoints of the JCAR017 RP2D identified in Phase 1, in the following three diseasecohorts:•…

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…

Evaluation of the intracellular pharmacokinetics of decitabine in patients with leukemia or myelodysplasia

The present study will be focused on exploring the intracellular pharmacokinetics of decitabine