Phase II Study of Olutasidenib as Maintenance Therapy After Stem Cell Transplant in Adults With IDH1-mutated Myeloid Cancers

What this Trial Is About

Researchers are evaluating the safety and tolerability of olutasidenib as a maintenance therapy for patients with IDH1-mutated myeloid malignancies after they have received a stem cell transplant. This phase II open-label study aims to learn how patients respond to olutasidenib in the post-transplant setting and assess various outcomes including progression-free survival, overall survival, relapse rates, and graft versus host disease. Starting 30 to 120 days after stem cell infusion, participants take olutasidenib by mouth twice daily for 28 days per cycle. These cycles repeat every 28 days for up to two years unless the disease progresses or unacceptable side effects occur. During the study, patients may have blood samples taken regularly and may undergo bone marrow biopsies, heart scans ECHOMUGA, and chest x-rays at screening. Participants will be closely monitored through clinical evaluations and laboratory tests throughout the study period, which can last up to two years. Researchers will measure safety outcomes, adverse events, and disease progression. The study includes follow-up to observe relapse and survival rates, along with assessments for graft versus host disease. The total participation time averages about one year for safety monitoring, with ongoing evaluations during treatment cycles.

A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies