RecruitingPhase 2NCT06707493

Ivosidenib as Post-HSCT Maintenance for AML

A Randomized, Placebo-Controlled Phase 2 Study of IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Acute Myeloid Leukemia Following Allogeneic Stem Cell Transplantation


Sponsor

Massachusetts General Hospital

Enrollment

75 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ivosidenib — a targeted drug that blocks a mutated enzyme called IDH1 — can prevent relapse when given as maintenance therapy after a stem cell transplant in people with a specific type of blood cancer (AML) that has an IDH1 mutation. **You may be eligible if...** - You are between 18 and 75 years old - You have acute myeloid leukemia (AML) with an IDH1 mutation (detected at any prior point) - You are planning to undergo an allogeneic (donor) stem cell transplant - Your blood counts and organ function meet minimum requirements - You are in reasonably good functional condition (ECOG 0-2) **You may NOT be eligible if...** - You do not have an IDH1 mutation in your leukemia - You have significant organ dysfunction - You have conditions that would make the drug or transplant unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvosidenib

Ivosidenib tablets are supplied as 50 mg, 200 mg, and 250 mg strengths, to be taken orally.

DRUGPlacebo

Placebo tablets are taken orally.


Locations(4)

Emory University Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06707493


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