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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02577406 | An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation | PHASE3 | COMPLETED | 319 | — | — | Dec 30, 2015 | Mar 25, 2024 | May 18, 2025 | 93 | United States, Australia +16 |
The time between randomization and death from any cause. Participants who drop-out or are alive at the end of trial will have their OS times censored at the time of last contact, as appropriate.
| Arm | Type | Description |
|---|---|---|
| AG-221 plus Best supportive care (BSC) | EXPERIMENTAL | Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days, plus BSC. |
| Conventional care regimen (CCR) | ACTIVE_COMPARATOR | Continuous 28-day cycles of BSC only, azacitidine subcutaneously (SC) plus BSC, low-dose cytarabine (LDAC) SC plus BSC, or intermediate-dose cytarabine (IDAC) intravenously (IV) plus BSC. Subjects will be assigned by the investigator to one of the CCR treatment options based on the investigator's assessment of subjects' eligibility. |
| Name | Type | Description |
|---|---|---|
| AG-221 | DRUG | Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days |
| BSC | OTHER | Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support |
| Azacitidine | DRUG | continuous 28-day cycles of azacitidine 75 mg/m2/day SC for 7 days, plus BSC |
| Low-dose cytarabine (LDAC) | DRUG | continuous 28-day cycles of cytarabine 20 mg SC twice a day (BID) for 10 days, plus BSC |
| Intermediate-dose cytarabine (IDAC) | DRUG | 28-day cycles of cytarabine 0.5 to 1.5 g/m2/day IV for 3 to 6 days, per standard institutional practice, plus BSC; only BSC given after IDAC therapy concludes per standard institutional practice |
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 60 years of age at the time of signing the ICF 2. Subject has primary (ie, de novo) or secondary (progression of MDS or myeloproliferative neoplasms (\[MPN\], or therapy-related) AML accor...