A Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

March 31, 2031

Conditions
Leukemia, B-Cell, ChronicLeukemia
Interventions
DRUG

Venetoclax

Venetoclax 400 mg orally once Daily

DRUG

Azacitidine

75 mg/m2 Subcutaneous (SC) or intravenous (IV) Daily with a continuous 7-day scheme or on a 5-on/2-off \[weekend\]/2-on schedule (5-0-2) in 28-day cycle

Trial Locations (1)

94805

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER