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Venetoclax vs Idarubicin with Cytarabine in Elderly AML Post-Remission
NCT04968015Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- May 2022
- Primary completion
- Aug 2025
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- venetoclax
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, randomised, open-label trial of venetoclax in acute myeloid leukemia (AML) (2 arms), sponsored by French Innovative Leukemia Organisation. Primary endpoint: Relapse Free Survival at 5 years. Started May 2022; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Venetoclax + Cytarabine
Venetoclax 600mg/day PO D1-14 + Cytarabine 50mg/m2/12h SC D1-5 per 28-day cycle
Idarubicin + Cytarabine
Idarubicin 8mg/m2 IV D1 + Cytarabine 50mg/m2/12h SC D1-5 per 28-day cycle
03
Who it enrols
Elderly patients (>= 60 years) with de novo AML in first complete remission (CR/CRi) following intensive induction with Idarubicin, Cytarabine, and Lomustine. Patients must have favorable or intermediate cytogenetics.
04
Endpoints
Primary
Relapse Free Survival
Secondary
Overall Survival
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