Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nelarabine/m2 · 1 trial · 1 indication
| 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...
Nelarabine/m2 is an investigational small molecule being studied for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. It is also being evaluated in chronic lymphocytic leukemia that has not responded to fludarabine or alkylating agents. The drug is in clinical development for these oncology indications.
Nelarabine/m2 is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain types of leukemia and lymphoma.
Nelarabine/m2 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities. It is still undergoing clinical evaluation to determine its safety and effectiveness.
Nelarabine/m2 has been studied in two completed clinical trials. NCT00003635 was a Phase 2 study in patients with chronic lymphocytic leukemia that had not responded to fludarabine or alkylating agents. NCT00406757 was a Phase 1 study in Japanese patients with leukemia or lymphoma, enrolling 13 participants.
Yes, Nelarabine/m2 is also known as 506U78. Clinical trial records refer to the drug by both names, with studies titled '506U78 in Treating Patients With Chronic Lymphocytic Leukemia' and 'Clinical Evaluation of Nelarabine (506U78) in Japanese Patients With Leukemia or Lymphoma'.