NCT07163793

Pilot Study of Reduced Venetoclax Exposure

A Pilot Study of Reduced Venetoclax Exposure in Patients With Acute Myeloid Leukemia in Complete Remission

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pilot Study of Reduced Venetoclax Exposure

Detailed description

A pilot single-arm clinical trial is proposed to assess the primary objective: the tolerability of 14-day Venetoclax cycles in acute myeloid leukemia (AML) patients who have achieved remission and are ineligible for intensive treatment. Participants in the study will transition to a maintenance regimen that reduces the Venetoclax dosage to 14 days per cycle while continuing the hypomethylating agent (HMA) used during induction. Treatment cycles will occur every 28 days. Participants will continue treatment on study until experiencing a grade 4 cytopenic event lasting more than 7 days, an adverse event requiring regimen modification, relapse, or death. Our primary hypothesis posits that AML patients receiving Venetoclax for 14 days per cycle will exhibit improved treatment tolerability with a reduced rate of grade 4 cytopenia compared to historical data from the VIALE A trial.

Conditions

• Acute Myeloid Leukemia in Remission

Interventions

Type	Name	Description
DRUG	Azacitidine	Given Day 1-7 with Venetoclax Day 1-14 every 28 days until off study
DRUG	Decitabine	Given Day 1-5 with Venetoclax Day 1-14 every 28 days until off
DRUG	Venetoclax	Venetoclax up to 400mg a day on Day 1-14 every 28 days until off in combination with Azacitidine or Decitabine

Timeline

• Start date: 2024-10-07
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2025-09-09
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study