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Administration of leukemia-reactive donor T cells after allogeneic stem cell transplantation or donor lymphocyte infusion to patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement

- To investigate the feasibility and safety of administration of donor leukemia-reactive T cells- To evaluate the persistence of leukemia-reactive T cells after administration- To evaluate whether administration of leukemia-reactive T cells leads to…

A Phase II, single arm, open label study of treatment-free remission in chronic myeloid leukemia (CML) chronic phase (CP) patients after achieving sustained MR4.5 on Nilotinib

The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…

A PHASE 1, OPEN-LABEL STUDY OF THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-LABELED IPI-145 AND THE ABSOLUTE BIOAVAILABILITY OF IPI-145 IN HEALTHY SUBJECTS

Primary: To evaluate the absorption, distribution, metabolism and excretion of IPI-145 following a single oral dose of 14C0IPI-145.To determine the absolute bioavailability of IPI-145 following a single oral dose of IPI-145 and an intravenous…

A Single arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment

The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…

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…

A single arm, phase II, open-label study to determine the efficacy of 100mg twice daily oral dosing of Midostaurin administered to patients with Agressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease

Objective of this study is to determine the efficacy of midostaurin in patients with ASM or MCL with/without an associated hematological clonal non-mast cell lineage disease.

An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response

To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remissionTo determine whether restarting of Imatinib in case of molecular relapse results in a…

A non-randomized, open-label study to characterize the pharmacokinetcs of Glivec/Gleevec (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other Glivec/Gleevec® indicated hematological disorders.

Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches

A phase I/ II study ;Efficacy and safety of alpha/ beta T- /CD19B-cell depleted allogeneic haematopoietic stem cells transplantation in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI)

Objective: To test feasibility and safety of alpha beta T-/CD19 B-cell depleted allo-SCT in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI)

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, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

Primary1. To assess the major (complete/partial) cytogenetic response (MCyR) rateSecondary1. To determine the duration of MCyR2. To determine the complete hematologic response (CHR) rate3. To determine the complete cytogenetic response (CCyR) rate4…

Efficacy and safety of recombinant asparaginase in infants ( < 1 year) with previously untreated acute lymphoblastic leukemia, a phase II clinical trial

This non-controlled multicentric phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase for first-line treatment of infants (&lt; 1 year of age at…

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.

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

Identification of predictive parameters for typhlitis in AML patients treated with intensive chemotherapy

To identify predictive parameters for typhlitis in AML patients treated with intensive chemotherapy.

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