Phase II study of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia.

ABSTRACT:

Purpose

To determine the efficacy and safety of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia (AML).

Patients and methods

A phase II, open-label, multicenter study was conducted with single-agent clofarabine in pediatric patients with refractory or relapsed AML. Clofarabine was administered intravenously over 2 hours at the pediatric maximum-tolerated dose (MTD) of 52 mg/m(2) daily for 5 consecutive days. Cycles were repeated every 2 to 6 weeks. Responses determined by an independent response review panel.

Results

The 42 patients treated on the study had a median age of 13 years (range, 2 to 22 years) and had received a median number of two (range, one to five) prior regimens. The response rate was 26% and included one complete r

SUBMITTER: Jeha S 

PROVIDER: S-EPMC2744276 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature