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Also known as Nelarabine
Nelarabine/m2 · 3 trials · 2 indications
MTD defined as the highest dose that no more than 1 dose limiting toxicity (DLT) occurs among 6 patients. Dose-limiting toxicity (DLT) defined based on drug related events only. DLT in the first treatment cycle used for the dose escalation.
| Arm | Type | Description |
|---|---|---|
| Continuous Infusion Nelarabine | EXPERIMENTAL | Starting dose 200 mg/m2 x 5 days |
| 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 | DRUG | - |
| 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. |
DISEASE CHARACTERISTICS: Diagnosis of refractory chronic lymphocytic leukemia Evidence of active disease after fludarabine or alkylator therapy Must meet one or more of the following criteria for active disease: Minimum of one of the following disease-related symptoms: Weight loss of 10% or more wit...
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Nelarabine/m2 is used in the treatment of lymphoid malignancies, specifically leukemias and lymphomas including acute lymphoblastic leukemia and lymphoblastic lymphoma. It is given as an injection at a dose of 400 mg/m2. The drug is being studied in patients with relapsed or refractory disease, as well as in Japanese patients with leukemia or lymphoma.
Nelarabine/m2 is developed by GSK plc, which trades under the ticker GSK. GSK is the company responsible for the clinical development of this injectable formulation of nelarabine.
Nelarabine/m2 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for the indications being studied. The Phase 1 program includes pharmacokinetic and pharmacodynamic evaluations in patients with relapsed or refractory lymphoid malignancies.
Nelarabine/m2 has been studied in clinical trials including NCT01094860, a Phase 1 pharmacokinetic and pharmacodynamic study in patients with relapsed or refractory lymphoid malignancies, and NCT00406757, a Phase 1 clinical evaluation in Japanese patients with leukemia or lymphoma. Both trials are completed.
Yes, nelarabine/m2 is another name for nelarabine, also known as nelarabine injection 400 mg/m2. The '/m2' refers to the dosing based on body surface area. It is the same active agent used in the treatment of leukemias and lymphomas.