Ivosidenib as Post-HSCT Maintenance for AML (NCT06707493) | Clinical Trial Compass
RecruitingPhase 2
Ivosidenib as Post-HSCT Maintenance for AML
United States75 participantsStarted 2026-01-16
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically confirmed diagnosis of IDH1(R132)-mutant acute myeloid leukemia (AML). IDH1 mutations could have been detected by any mutational technique at any prior point including at diagnosis or remission.
* Between the ages of 18 and 75 years
* Will undergo allogeneic hematopoietic stem cell transplantation (HSCT) for their malignancy. Conditioning may be either conventional myeloablative (MAC) or reduced intensity conditioning (RIC). There will be no restrictions on type of graft source.
* ECOG performance status ≤ 2
* Participants must have normal organ and marrow function as defined below:
* Absolute neutrophil count ≥ 1000/µL without growth factor support (e.g. GCSF) in the previous 7 days.
* Platelet count ≥ 50,000/µL without transfusional support in the previous 7 days.
* AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 3x institutional upper limit of normal (ULN)
* Direct bilirubin \< 2.0 mg/dL
* Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
* LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram
* Female patients of childbearing potential must have a negative pregnancy test
* The effects of ivosidenib on the developing human fetus are unknown. For this reason female participants of child-bearing potential and male participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and thro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My AML has an IDH1 mutation — given that ivosidenib specifically targets IDH1, is this trial worth discussing as a maintenance option after my stem cell transplant, or would standard monitoring after HSCT be a better path for me?
2Since this is a Phase 2 trial, what do we currently know about the safety of using ivosidenib as maintenance therapy after a stem cell transplant, and what risks or side effects should I be prepared for in this particular setting?
3The trial is measuring relapse-free survival — based on my specific disease profile and transplant status, how does the potential to extend relapse-free survival here compare to what I might expect without any maintenance therapy?
4What would the practical demands of this trial look like for me day-to-day, such as how often I'd need to come in for monitoring visits after my transplant, and is that realistic given my situation?
5If I don't enroll in this trial, are there other approved maintenance strategies after HSCT that my care team would recommend for someone with an IDH1-mutated AML like mine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relapse-Free Survival (RFS)
Timeframe: Time of randomization to 24 months post-randomization, death, or disease relapse whichever occurs first.