99 results
The primary objective is to assess the treatment effect on response rate (MDS: either completeremission [CR], partial remission [PR], or marrow CR; JMML: either clinical completeremission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28…
Primary Objectives:Safety Run-in PartTo establish a safe and tolerable dose of azacitidine to be used in the randomized part of thestudy.Randomized PartTo evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after…
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of selinexor added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…
The overall study objective is to evaluate the safety and efficacy of NiCord®: single ex-vivo expanded cord blood unit transplantation in patients with hematological malignancies following myeloablative therapy.
To test transplantation-related mortality after an innate allo-SCT defined as alpha/beta T-cell depleted stem cell support combined with a *low dose DLI*.
Although DC vaccinations have been used in allo-HCT settings, no previous studies have been performed using a CBDC vaccine after CBT. This study will therefore be subdivided into 2 parts:- Part A: to determine a safe dose of the vaccination, and -…
Primary Objective• To investigate the feasibility and safety of administration of donor HA-1 TCR transduced virus-specific T-cells after allo-SCT.Secondary Objectives• To evaluate the persistence of donor HA-1 TCR transduced virus-specific T-cells…
The objective is to define the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is…
The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT…
To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.
Primary Objective:To determine the efficacy of ponatinib in patients with CML in CP, AP or BP or with Ph+ ALL who either:are resistant or intolerant to either dasatinib or nilotinib,Or:have the T315I mutation.Secondary Objectives:* To further…
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of Lenalidomide added to standard induction chemotherapy for AML and select the feasible dose level for part B of the study2. To assess in a randomized…
• To assess feasibility and safety of a sequential treatment regime in which standard intensive chemotherapy (fludarabin-amsacrin-cytarabin) is directly followed by standard allogeneic stem cell transplantation (T cell depleted RIC alloSCT with…
Primary objective(s)• To evaluate the efficacy of blinatumomab to induce complete MRD responseKey secondary objective for patients with Ph-negative ALL • To evaluate the effect of blinatumomab on hematological relapseOther Secondary objectives• To…
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
The objective of this study is to provide evidence that it is likely that the application of haploidentical stem cell with NK cell alloreactive donors results in a low risk of AML recurrence and therefore in a higher probability of progression-free…
• To evaluate the efficacy of the transfer of multiantigen specific T cells by measuring the appearance or expansion (if antigenic specific donor derived cells are already present in the circulation of the patient at time of infusion) of antigen…
To investigate the efficacy, safety, and pharmacokinetics of volasertib in combination with low-dose cytarabine versus investigator*s choice of anti-leukemic treatment in patients with relapsed or refractory acute myeloid leukemia with no…
To investigate the feasibility and efficacy of a maximum of 6 cycles of Chlorambucil with Rituximab plus Lenalidomide at the RDL.
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)