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Azacitidine and Venetoclax for MRD in AML Before Stem Cell Transplant
NCT06773208Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2025
- Primary completion
- Jan 2027
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Small Molecules
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of azacitidine and venetoclax in acute myeloid leukemia (AML), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Rate of MRD conversion at 1 year. Started Jan 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Azacitidine and Venetoclax
Azacitidine 75 mg/m2 daily, on days 1-7, given IV or SC. Venetoclax 400 mg orally daily on days 1-28.
03
Who it enrols
Adult patients with de-novo AML (non-APL) in morphologic remission but with positive measurable residual disease (MRD) after 1-3 cycles of intensive chemotherapy, eligible for allogeneic transplant.
04
Endpoints
Primary
Rate of MRD conversion
Secondary
Degree of MRD decrease
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