Actively Recruiting
Ivosidenib as Post-HSCT Maintenance for AML
Led by Massachusetts General Hospital · Updated on 2026-04-28
75
Participants Needed
4
Research Sites
206 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
S
Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ivosidenib as Post-HSCT Maintenance for AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of IDH1(R132)-mutant acute myeloid leukemia (AML) confirmed by mutation testing
- Age between 18 and 75 years
- Planned allogeneic hematopoietic stem cell transplantation (HCT) with any graft source
- ECOG performance status of 2 or less
- Normal organ and marrow function: neutrophil count ≥ 1000/µL without recent growth factor support, platelet count ≥ 50,000/µL without recent transfusions
- Liver function tests (AST, ALT, alkaline phosphatase) less than 3 times the upper limit of normal
- Direct bilirubin less than 2.0 mg/dL
- Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
- Left ventricular ejection fraction (LVEF) ≥ 40% by heart scan
- Negative pregnancy test for females of childbearing potential
- Agreement to use contraception during treatment and for 90 days after last dose
- Ability to understand and sign informed consent
- No evidence of relapse or refractory disease before treatment start
- Willingness to start treatment between 45 and 90 days post-transplant
- No systemic infection requiring IV antibiotics within 7 days before treatment
- Chimerism studies showing ≥ 70% donor cells in blood or bone marrow
- No acute graft versus host disease requiring significant steroid treatment or increased immunosuppression
- Allowed GVHD prophylaxis or treatment agents per study guidelines
You will not qualify if you...
- Prior allogeneic hematopoietic stem cell transplantation
- Morphologic relapse or refractory AML within 42 days before study entry
- History of other malignancies unless disease-free for 5 years or limited to certain skin or cervical cancers
- Active hepatitis B or C infection
- Congestive heart failure classified as New York Heart Association (NYHA) class 3 or 4
- Heart dysfunction with left ventricular ejection fraction below 40%
- History of dangerous heart rhythm problems or long QT syndrome
- QTc interval ≥ 450 ms or other risk factors for arrhythmias at screening
- Uncontrolled illnesses that would interfere with study participation
- Use of investigational agents not approved for any indication during the study
- Evidence of relapsed or residual disease before starting treatment
- Inadequate hematological or organ function at treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
Amir T Fathi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here