A phase lb feasibility study of the combination of panobinostat and midostaurin in recipients of allogeneic stem cell transplantation with Flt3-ITD AM
Recruiting
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NL-OMON29431
- Lead Sponsor
- HOVON Data Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Eligibility for registration
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Exclusion Criteria
Eligibility for registration
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To asses the safety and feasibility of post-transplant<br>panobinostat combined with midostaurin in patients with<br>adverse risk AML/RAEB with FLT3-ITD with high allelic ratio in<br>terms of dose limiting toxicity.
- Secondary Outcome Measures
Name Time Method To assess efficacy in terms of:<br /><br>•Complete hematological remission rate at 3, 6, and 12 months post alloHSCT <br /><br>•Immunological remission (residual disease assessed by multicolor flowcytometry) at 6 months post alloHSCT<br /><br>•Relapse/progression rate at 3, 6, and 12 months post alloHSCT<br /><br>•Overall survival (OS) from alloHSCT<br /><br>•Progression free survival (PFS) from alloHSCT with relapse (for patients in CR) and progression (for patients in PR) and death from any cause as events<br /><br>•Engraftment and chimerism at 3, 6, and 12 post alloHSCT <br /><br><br /><br>To assess toxicity in terms of:<br /><br>•The incidence and nature of (serious) adverse events<br /><br>•The incidence and severity of acute and chronic GvHD up to 12 months post alloHSCT<br /><br>•NRM up to 12 months post alloHSCT<br /><br>•Number and percentage of registered patients starting protocol treatment<br /><br>•Number and percentage of patients receiving post-transplant epigenetic therapy after alloHSCT<br>