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Ivosidenib as Post-HSCT Maintenance for AML

NCT06707493 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-28

No results posted yet for this study

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).

Conditions

  • IDH1 Mutation
  • Acute Myeloid Leukemia (AML)
  • Hematopoietic Stem Cell Transplant (HSCT)

Interventions

DRUG

Ivosidenib

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

DRUG

Placebo

Placebo tablets are taken orally.

Sponsors & Collaborators

Principal Investigators

  • Amir T Fathi, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2028-01-01
Completion
2030-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT06707493 on ClinicalTrials.gov