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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00406757 | Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma | PHASE1 | COMPLETED | 13 | — | — | Aug 30, 2006 | Jul 15, 2009 | Nov 13, 2017 | 3 | Japan |
| Arm | Type | Description |
|---|---|---|
| Pediatric Arm 1 | ACTIVE_COMPARATOR | Cycle 1: Nelarabine 400mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. Cycle 2 and subsequent Cycles: Nelarabine 650mg2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. |
| Pediatric Arm 2 | ACTIVE_COMPARATOR | Cycle 1 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. |
| Adult Arm 1 | ACTIVE_COMPARATOR | Cycle 1: Nelarabine 1000mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. |
| Adult Arm 2 | ACTIVE_COMPARATOR | Cycle 1 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. |
| Pediatric Arm 3 | ACTIVE_COMPARATOR | Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5. |
| Name | Type | Description |
|---|---|---|
| Nelarabine injection 400mg/m2 | DRUG | Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5. Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5. |
| Nelarabine injection 650mg/m2 | DRUG | Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5. |
| Nelarabine injection 1000mg/m2 | DRUG | Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5. Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5. |
| Nelarabine injection 1500mg/m2 | DRUG | Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5. |
Inclusion Criteria: * Histologic or cytogenetic documented diagnosis of T-ALL or T-LBL. * Disease that is refractory to at least one prior chemotherapy regimen, or has relapsed following complete remission to at least one prior chemotherapy regimen. * At least 4 weeks since the last dose of prior l...