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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05183035 | Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) | PHASE3 | RECRUITING | 130 | — | — | Oct 1, 2022 | Apr 1, 2031 | Apr 28, 2026 | 89 | United States, Australia +18 |
| Arm | Type | Description |
|---|---|---|
| Arm A: Control Arm without Venetoclax | ACTIVE_COMPARATOR | During Cycle 1 (42-day-cycles), participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. Gemtuzumab 3 mg/m\^2 will be given on Day 6 (only for participants with CD33 expression on leukemia blasts). During Cycle 2 participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. After Cycle 2 participants are assessed for HSCT or azacitidine maintenance therapy. |
| Arm B: Experimental Arm with Venetoclax | EXPERIMENTAL | During Cycle 1 (42-day-cycles), participants will receive 300 mg adult dose equivalent of venetoclax once on Day 1 followed by 600 mg adult dose equivalent of venetoclax on Days 2-21. Participants will also receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 8-12. Gemtuzumab 3 mg/m\^2 will be given on Day 13 (only for participants with CD33 expression on leukemia blasts). During Cycle 2, participants will receive 600 mg adult dose equivalent of venetoclax on Days 1-21. Participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. After Cycle 2 participants are assessed for HSCT or azacitidine maintenance therapy in combination with venetoclax. |
| Name | Type | Description |
|---|---|---|
| Fludarabine | DRUG | Intravenous (IV) infusion |
| Cytarabine | DRUG | Intravenous (IV) infusion |
| Gemtuzumab Ozogamicin | DRUG | Intravenous (IV) infusion |
| Azacitidine | DRUG | Intravenous (IV) infusion or subcutaneous injection |
| Venetoclax | DRUG | Orally via tablet or powder suspension |
Inclusion Criteria * Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101/APAL2020D. (This is only applicable for participants in USA/Canada/Australia/New Zealand sites/Blood Cancer United territory). * Participants must be ≥ 29 days of age and ≤ 21...