Olutasidenib
Sponsors
National Cancer Institute (NCI), M.D. Anderson Cancer Center, City of Hope Medical Center, Justin Watts, MD, University of California, Davis
Conditions
AML (Acute Myeloid Leukemia)Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative NeoplasmAcute Myeloid Leukemia Post Cytotoxic TherapyAcute Myeloid Leukemia, Myelodysplasia-RelatedAdvanced Myeloproliferative NeoplasmsCholangiocarcinomaChronic Myelomonocytic Leukemia
Phase 1
Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
RecruitingNCT06445959
Start: 2024-08-29End: 2029-06-30Target: 78Updated: 2025-10-24
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
RecruitingNCT06543381
Start: 2025-01-17End: 2027-02-05Target: 15Updated: 2026-03-05
Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia
Not yet recruitingNCT07411586
Start: 2026-08-31End: 2029-01-14Target: 20Updated: 2026-02-17
Phase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
RecruitingNCT05564390
Start: 2024-06-18End: 2029-05-15Target: 2000Updated: 2026-04-03
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
RecruitingNCT06566742
Start: 2024-12-10End: 2029-08-31Target: 15Updated: 2026-03-04
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm
RecruitingNCT06597734
Start: 2025-01-28End: 2029-08-31Target: 45Updated: 2025-10-09
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
RecruitingNCT06668584
Start: 2024-12-31End: 2029-12-31Target: 31Updated: 2026-03-04
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
RecruitingNCT06782542
Start: 2026-05-01End: 2029-05-01Target: 16Updated: 2026-02-23
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
RecruitingNCT07032727
Start: 2025-09-12End: 2029-06-01Target: 68Updated: 2025-12-15
Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy)
Not yet recruitingNCT07153497
Start: 2026-05-27End: 2030-04-26Target: 132Updated: 2026-04-03
Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent
RecruitingNCT07304011
Start: 2025-12-17End: 2032-01-01Target: 28Updated: 2026-03-05
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
Not yet recruitingNCT07471841
Start: 2026-05-01End: 2029-06-01Target: 25Updated: 2026-03-13