Cohen MH et al. - In a study to describe the clinical trials leading to FDA approval of nelarabine for the treatment of pts with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens, on October 28, 2005, the FDA granted accelerated approval for nelarabine for treatment of pts with relapsed or refractory T-ALL/T-LBL after at least 2 prior regimens Methods
2 phase II trials, 1 conducted in pediatric pts and the other in adult pts, were reviewed
Pts were in their first or subsequent relapse and/or were refractory to first-line therapy
The dose and schedule of i.v. nelarabine in the pediatric and adult studies were 650 mg/m2 per day daily for 5 days and 1500 mg/m2 i.v. on days 1, 3, and 5, respectively
Treatments were repeated every 21 days
Study endpoints were the rates of complete response (CR) and CR with incomplete hematologic or bone marrow recovery (CR*)
Results
Pediatric efficacy population consisted of 39 pts who had relapsed after, or had been refractory to, 2 or more induction regimens
CR to nelarabine treatment was observed in 5 pts and CR+CR* was observed in 9 pts
The adult efficacy population consisted of 28 pts
CR to nelarabine treatment was observed in 5 patients and CR+CR* was observed in 6 pts
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