Study of Ivosidenib as Maintenance Treatment After Stem Cell Transplant in Adults with IDH1-Mutant Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating ivosidenib, a mutant IDH1 inhibitor, compared to a placebo in patients with IDH1-mutant acute myeloid leukemia AML after they have undergone hematopoietic stem cell transplantation HCT. This phase 2, randomized, placebo-controlled, single-blinded, multi-center study aims to see if ivosidenib can help prevent AML relapse post-transplant. The drug is approved for other uses but not yet for this specific indication. Participants start treatment with either ivosidenib or placebo orally once daily in 28-day cycles, beginning 45 to 90 days after their stem cell transplant. The treatment phase lasts up to 24 months, during which study visits and assessments are conducted regularly. After completing treatment, participants are followed for an additional 12 months to monitor their health. Throughout the study, participants undergo screening and regular evaluations including blood tests and monitoring for treatment-related side effects, relapse, and graft versus host disease. The main outcome measured is relapse-free survival up to 24 months after randomization. Secondary outcomes include overall survival, incidence of adverse events, and disease relapse rates. The total participation time is about 3.5 years from screening through follow-up.

Ivosidenib as Post-HSCT Maintenance for AML