What is the role of nelarabine in the treatment of acute lymphoblastic leukemia (ALL)?

Updated: Jul 17, 2018
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

In October 2005, the FDA granted accelerated approval for nelarabine for the treatment of T-cell ALL (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease had not responded to or relapsed following treatment with at least two chemotherapy regimens. Approval was based on two phase II trials, one conducted in pediatric patients and the other in adult patients. In the pediatric trial, of the 39 patients who had relapsed or had been refractory to two or more induction regimens, 5 patients (13%) had a CR and 9 patients (23%) had a CR with incomplete hematologic or bone marrow recovery. [69]


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