Actively Recruiting
Phase 1b Study Evaluating Gilteritinib Combined With Ivosidenib or Enasidenib in Adults With Relapsed or Refractory Acute Myeloid Leukemia Having FLT3 and IDH1IDH2 Mutations
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-22
18
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and appropriate dosing of combining the drugs gilteritinib with either ivosidenib or enasidenib in adults with relapsed or refractory acute myeloid leukemia AML who have specific gene mutations called FLT3 and IDH1 or IDH2. This phase 1b study aims to find the highest dose of these combinations that causes few or mild side effects and then test that dose in new participant groups. Participants will be assigned to one of two groups one taking gilteritinib combined with ivosidenib, and the other taking gilteritinib combined with enasidenib. Both combinations are taken daily in continuous 28-day cycles at assigned dose levels. The study will gradually increase doses to determine the maximum tolerated dose for each combination. During the study, participants will have regular visits to monitor side effects and toxicities over one year. Researchers will assess clinical responses and safety through examinations, laboratory tests, and patient reports. The total study duration extends up to April 2027, with ongoing monitoring of participants health and treatment effects throughout this period.
CONDITIONS
Brief Title
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Research Team
E
Eytan Stein, MD
A
Aaron Goldberg, MD,PhD
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