A phase I/II feasibility study of the combination of panobinostat and decitabine prior to donor lymphocyte infusion in recipients of allogeneic stem cell transplantation with poor and very poor-risk AM
Completed
- Conditions
- (very) poor risk AML or RAEB with IPSS >= 1.5
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Eligibility for registration:
- Patients with poor-risk or very poor-risk AML or RAEB with IPSS ¡Ý 1.5 , (see appendix D). During the phase I part only very poor-risk patients will be included
Exclusion Criteria
Eligibility for registration:
- History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma ¡°in situ¡± of the cervix or breast
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part I<br /><br>To asses the safety and feasibility of post-transplant panobinostat combined with decitabine to a regimen of Tcell replete RIC alloHSCT and DLI and select the dose<br>level for part II of the study.<br /><br>Part II<br /><br>Assess the feasibility and efficacy of post-transplant panobinostat combined with decitabine to a regimen of Tcell replete RIC alloHSCT and DLI in patients with (very)<br>poor-risk AML.
- Secondary Outcome Measures
Name Time Method Assess efficacy in terms of complete remission rate, overall and progression free survival.<br>Assess toxicity.