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 range18 Years – 75 Years
SexALL
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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…
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.