NCT07392242

A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

A Phase II Study of IDH1 Inhibition With Ivosidenib as Maintenance Therapy After Ivosidenib, Azacitidine, and Venetoclax for Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to find out whether a 3-drug combination of ivosidenib, azacitidine, and venetoclax followed by maintenance therapy with ivosidenib alone is an effective treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. Maintenance therapy is additional treatment given to help keep cancer from coming back after it has disappeared following the first course of treatment. The researchers will also look at the safety of the treatment approach and what kind of a time commitment it involves for participants.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Ivosidenib	Ivosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter)
DRUG	Azacitidine	Azacitidine (IV or SC per institutional preference, days 1 through 7)
DRUG	Venetoclax	Venetoclax (days 1 through 14)

Timeline

• Start date: 2026-01-27
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2026-02-06
• Last updated: 2026-03-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study