Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07130695 | Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation | PHASE1 | RECRUITING | 15 | — | — | Feb 2, 2026 | Oct 31, 2030 | Feb 6, 2026 | 1 | United States |
Feasibility defined as the number of participants with 75% protocol treatment compliance for a duration of at least 4 cycles (to include protocol defined dose delays), or until disease relapse or allogeneic hematopoietic stem cell transplant (alloHCT).
Incidence of grade ≥4 adverse events (AEs) attributable to study drug for duration of treatment on study
| Arm | Type | Description |
|---|---|---|
| Olutasidenib Investigational Agent Administration | EXPERIMENTAL | 150 mg by mouth twice daily. |
| Name | Type | Description |
|---|---|---|
| Olutasidenib Investigational Agent Administration | DRUG | Twice daily olutasidenib maintenance therapy |
Inclusion Criteria: * Histologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML). IDH1 mutation may be identified by NGS or PCR based methods and identified at time of diagnosis or any other time point prior to enrollment....