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Olutasidenib

DRUG13 trials

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 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
National Cancer Institute (NCI)Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Myelodysplasia-Related +2
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
M.D. Anderson Cancer CenterChronic Myelomonocytic Leukemia, Clonal Cytopenia of Undetermined Significance, Myelodysplastic Syndromes
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
M.D. Anderson Cancer CenterAdvanced Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, IDH1-mutated Higher-Risk Myelodysplastic Syndromes
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
M.D. Anderson Cancer CenterMyeloid Malignancies
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
Justin Watts, MDAcute Myeloid Leukemia, IDH1 Mutation
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
M.D. Anderson Cancer CenterIDH1-Mutated Malignancies, Mutations, Targeted Therapy
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
National Cancer Institute (NCI)Acute Myeloid Leukemia, Myelodysplastic Syndrome
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
University of California, DavisAcute Myeloid Leukemia
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
Timothy PardeeIDH1 Mutation, Relapsed / Refractory AML
Start: 2026-05-01End: 2029-06-01Target: 25Updated: 2026-03-13

Phase 4

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