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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT07082452
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax 400 mg orally once Daily
  • Azacitidine — DRUG
    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

Study Details

Combination of azacitidine (AZA) for 7 days every 28 days with a continuous daily exposure to Venetoclax (VEN), an oral bcl-2 inhibitor, is now approved for the treatment of acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy due to age (\>75 years) or comorbidities. VEN+AZA showed significant overall response rate and survival benefit but combination carries a risk of considerable toxicity (such as profound/prolonged cytopenia and infections) before but also after remission. These toxicities make it difficult to apply the recommended treatment regimen, in particular the continuous daily intake of VEN. Recent reports suggest that reducing VEN duration per cycle seems safe and feasible. We propose to investigate a reduced-intensity VEN regimen (7-day dosing/28) versus the standard continuous VEN therapy (28-day dosing/28), combined with AZA, with the primary goal of maintaining efficacy while reducing associated toxicity.

Key Dates

Start date
Sep 30, 2025
Status verified
Jul 2025
Primary completion
Sep 30, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
262 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Venetoclax (7 days) + Azacitidine
    Arm A (experimental): Patients will receive venetoclax for a total of seven days. * Azacitidine 75 m 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 * Venetoclax 400 mg orally once Daily on Days 1 - 7, in case of AZA treatment with a continuous 7-day scheme OR Venetoclax 400 milligram (mg) Daily on Days 1 - 5 and Day 8-9 in case of AZA treatment with a 5-0-2 scheme.
  • Active Comparator: Arm B: Venetoclax (28 days) + Azacitidine
    Arm B (standard): Patients will receive venetoclax for a total of 28 days (before remission), according to VIALE-A protocol. * Azacitidine 75 mg/m2 Subcutaneous (SC) or 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. * Venetoclax 400 mg orally once Daily on Days 1 - 28.

Primary Outcome Measure

Proportion of subjects with complete remission or complete remission with incomplete marrow recovery (CR/CRi) [ Time Frame: at any time point during the study (at 30 days, 60 days, 3 years) ]

Central Contacts

Related Studies