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Randomized maintenance therapy with Azacitidine (Vidaza) in older patients (>=
60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t)

- To assess, in a randomized study the value of Azacitidine as post remission therapy (in comparison to observation) in elderly patients with AML, RAEB or RAEB-t with respect to the disease free survival.- In addition, post remission Azacitidine…

Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL), a phase III clinical trial

This multicentre phase III study is designed to assess the efficacy and safety of recombinant versus E-Coli derived Aaparaginase from Medac, during treatment of children with newly diagnosed ALL according to the DCOG ALL-10 protocol.Futhermore: To…

A phase 3 randomized, double-blind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy + Midostaurin (PKC412) (IND# 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated Acute Myeloid Leukemia (AML)

To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.

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

Clinical effectiveness and safety of pooled, random donor platelet concentrates, leucoreduced and stored up to seven days either in additive solution with and without pathogen reduction or plasma in hemato-oncological patients.
(The TriPlate study)

To assess the non-inferiority of PAS III-PC and PR-PAS III-PC compared to plasma-PC in terms of recovery, estimated by the 1-hour CCI post transfusion.

A phase III randomized, open-label, multi-center study of nilotinib versus imatinib in adult patients with philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have suboptimal cytogenetic response (CyR) ib unatubub

To evaluate the CCyR rate at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response on imatinib.

The efficacy of an on-line coaching program focussing on the promotion of an active lifestyle in children after medical cancer treatment.

The goal of this study is to test the greater efficacy of the *COME ON, move on!* program in children, who received medical treatment for cancer, compared to pediatric physical therapy treatments without intensive coaching by Internet. This new…

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

Randomized study to assess the added value of Laromustine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or myelodysplasia (MDS) (RAEB with IPSS >= 1.5)

Primary objectivesPart A: To determine the feasibility of Laromustine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS³1.5 in a prospective comparison to standard…

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

Dose-reduced versus standard conditioning followed by allogeneic stem cell Transplantation in patients with MDS or sAML: A randomised phase III study

The present study will be a multicenter, prospective phase III-study comparing dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.

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…

An open label, randomised, muliticentre Phase III Trial of Dasatnib (SPRYCEL®) vs standard dose Imatininb (400mg) in the treatment of subjects with newly diagnosed chronic phase Philadelphia chromosome positive chronic myeloid leukaemia (CML).

To compare the best confirmed complete cytogenetic response (CCyR) rates within 12 months in newly diagnosed chronic phase CML subjects treated with dasatinib versus imatinib

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 III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients * 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy

To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low-dose cytarabine in patients * 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction…

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.

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 Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

The chief aim of the proposed study is to compare the safety and efficacy of NiCord® single ex vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following…

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…