(very) poor risk AML or RAEB with IPSS >= 1.5
Conditions
Interventions
Panobinostat combined with decitabine in the setting of RIC-alloHSCT
The setting, framework of RIC-alloHSCT is detailed as follows:
- T cell replete RIC alloHSCT with a short-course posttransplant G
Sponsors
HOVON
Eligibility
Inclusion criteria
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 - Eligibility for continuation with intensive induction/consolidation chemotherapy - Eligible for allogeneic donor search (related/unrelated) 18-70 years, inclusive - Written informed consent Eligibility for start protocol treatment: - Poor-risk or very poor-risk AML or RAEB with IPSS >= 1.5. During the phase I part only very poor-risk patients will be included. - Responsive disease (< 10% blasts at 3 and/or 4 weeks after start of induction cycle II) - Recovery of mucositis after preceding chemotherapy - Absence of active opportunistic infections - Absence of active CNS localisation - HLA-compatible donor available (8/8 matched unrelated donor or fully matched sibling donor) - WHO-performance status 0-2 - Written informed consent
Exclusion criteria
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 - Known HIV-positivity - Pregnant or breast-feeding female patients Eligibility for start protocol treatment: - Severe cardiac dysfunction (NYHA classification II-IV, see appendix H) - Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix G) - Severe neurological or psychiatric disease - Significant hepatic dysfunction (serum bilirubin or transaminases >= 5 times upper limit of normal) - Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration) - Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule - Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I 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 level for part II of the study. Part II 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) poor-risk AML. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess efficacy in terms of complete remission rate, overall and progression free survival. Assess toxicity. | — |
Contacts
Public ContactJ.J. Cornelissen
Erasmus Medical Center, Daniel den Hoed Cancer Center, Department of Hematology, P.O. Box 5201
Outcome results
None listed