s 4 to greater than 195 weeks. The recommended duration of therapy has not been established. In clinical trials, treatment was generally continued until there was evidence of disease progression, unacceptable toxicity, the patient became a candidate for bone marrow transplant, or the patient no longer continued to benefit from treatment.
Children and Adolescents
650 mg/m2/day IV over 1 hour for 5 consecutive days repeated every 21 days led to complete response (CR) (<= 5% bone marrow blasts, no other evidence of disease, and full hematologic recovery) plus CR without hematologic recovery rate of 23% in 39 pediatric patients. The median overall survival time was 13.1 weeks. The recommended duration of therapy has not been established. In clinical trials, treatment was generally continued until there was evidence of disease progression, unacceptable toxicity, the patient became a candidate for bone marrow transplant, or the patient no longer continued to benefit from treatment.
For the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL)†.
Intravenous dosage
Adults
Multiple regimens have been studied. In a phase I study of 24 patients with relapsed or refractory CLL and 11 patients with relapsed or refractory T-cell prolymphocytic leukemia, 20 to 50 mg/kg/day IV over 1 hour for 5 days per cycle or 1500 to 2900 mg/m2 IV on days 1, 3, and 5 (repeated every 21 to 28 days) led to overall response rates (ORR) of 20% (complete response (CR), 0%) and 15% (CR, 5%), respectively; also, 1200 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 to 28 days) in combination with fludarabine resulted in an ORR of 63% (CR, 13%) in the same study. Most patients (70%) in this study had fludarabine refractory disease. In another phase I study, 3 of 10 patients with refractory T- or B-cell CLL had a partial response (no CR) following treatment with nelarabine 5 to 75 mg/kg/day IV over 1 hour for 5 days per cycle.
†Indicates off-label use
MAXIMUM DOSAGE
The suggested maximum tolerated dose (MTD) for nelarabine is dependent on patient performance status, other chemotherapy agents or radiation given in combination, and disease state. If questions arise, clinicians should consult the appropriate references to verify the dose.
Adults
In clinical trials, a dose of 2200 mg/m2 IV on days 1, 3, and 5 resulted in significant grade 3 ascending sensory neuropathy in 2 patients. MRI eva luations in these patients demonstrated a demyelinating process in the cervical spine.
Elderly
Maximum dosage information not available.
Adolescents
Maximum dosage information not available.
Children
Maximum dosage information not available.
DOSING CONSIDERATIONS
Hepatic Impairment
Nelarabine has not been studied in patients with hepatic impairment; specific guidelines for dosage adjustments in hepatic impairment are not available. The risk of severe adverse reactions may be higher in patients with severe hepatic impairment (bilirubin > 3 mg/dl); these patients should be closely monitored during nelarabine therapy.
Renal Impairment
Specific guidelines for dosage adjustments in renal impairment are not available. No dosage adjustment is required for patients with creatinine clearance >= to 50 ml/minute. There are insufficient data to support a dose recommendation for creatinine clearance < 50 ml/minute.
ADMINISTRATION
CAUTION: Observe and exercise usual cautions for handling, preparing, and administering cytotoxic drugs.
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