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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06448013 | A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia | PHASE1 | RECRUITING | 22 | — | — | Mar 7, 2025 | Dec 31, 2030 | Dec 15, 2025 | 1 | United States |
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
| Arm | Type | Description |
|---|---|---|
| Dose Escalation + Dose Expansion | EXPERIMENTAL | Participants found to be eligible to take part in this study, you will be assigned to a dose level of ziftomenib based on when you join this study. Up to 4 dose levels of ziftomenib will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the recommended dose of ziftomenib is found. |
| Name | Type | Description |
|---|---|---|
| Venetoclax | DRUG | Given by PO |
| Gemtuzumab | DRUG | Given by IV |
| Ziftomenib | DRUG | Given by PO |
Inclusion Criteria: 1. Age ≥ 3 year to 21 years 2. Karnofsky for children \>16yo and Lansky \<16yo. 3. Relapsed/refractory AML, or MPAL with a myeloid phenotype. 1. Evidence of leukemia (AML, MPAL with a myeloid phenotype) in the bone marrow as detected by morphology or molecular diagnostics. ...