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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07211958 | Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation | PHASE3 | RECRUITING | 468 | — | — | Nov 25, 2025 | Jan 1, 2031 | May 20, 2026 | 24 | Australia, Georgia +7 |
| Arm | Type | Description |
|---|---|---|
| Revumenib + Intensive Chemotherapy | EXPERIMENTAL | Participants will receive revumenib plus an intensive chemotherapy regimen. |
| Placebo + Intensive Chemotherapy | PLACEBO_COMPARATOR | Participants will receive placebo plus an intensive chemotherapy regimen. |
| Name | Type | Description |
|---|---|---|
| Revumenib | DRUG | Participants will receive revumenib orally. |
| Placebo | DRUG | Participants will receive placebo (non-active agent) orally. |
| Intensive Chemotherapy Regimen | DRUG | Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion. |
Key Inclusion Criteria: * Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy. * Presence of an NPM1 mutation. * Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \>65 years old); Karnofsky or Lansky ≥40. * Have a life expec...