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Allogeneic Stem Cell Transplantation (SCT) for children and adolescents with acute lymphoblastic Leukaemia (ALL)

This study has been transitioned to CTIS with ID 2024-512657-24-00 check the CTIS register for the current data. Stratum 1:To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu) results in a non inferior survival as…

Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

The Primary Objectives of the Phase 1b are: • To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory ALL • To determine the maximum…

A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome

Primary objective- To evaluate the efficacy of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormonTM)/G-CSF (NeupogenTM) in terms of hematological improvement (HI) as defined by the modified response…

A phase III multi-center, open label, randomised study of optimised imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

Primary* To compare the efficacy (Major Molecular Response, MMR, rate at 12 months) Secondary* To compare the rate of durable MMR at 24 months in patients with a MMR at 12 months* To compare the rate, time to and duration of complete cytogenetic…

A Phase 3 Open-Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation(HSCT) Consolidation.

Quizartinib selectively inhibits survival pathways that block apoptosis by inhibiting FLT3. Quizartinib inhibits proliferation of FLT3-dependent cell lines, and is effective in human leukemia tumor xenograft models of AML. Data from the Phase 1 and…

Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia

1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10.This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1…

A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute prOmyelocytic leukemia.

To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen).

International randomized phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukemia

The main objective of this treatment protocol is to study the efficacy on the treatment response after adding a single gift of Mylotarg. Furthermore, monitoring of toxicity and long term efficacy is also important.

A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Low-Blast Acute Myelogenous Leukemia

Primary• To determine in patients with higher-risk myelodysplastic syndrome (HR MDS), chronic myelomonocytic leukemia (CMML), and low-blast acute myelogenous leukemia (AML) whether the combination of pevonedistat and azacitidine improves event-free…

A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 versus Treatment Choice (TC) in
Adults with Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT).

Primary Objective:Efficacy:· Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.Secondary Objectives:Safety:· Assess the safety and…