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

NCT07392242 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-06

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Kuo-Kai Chin, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392242 on ClinicalTrials.gov