Phase II Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia

Author:

Jeha Sima1,Gaynon Paul S.1,Razzouk Bassem I.1,Franklin Janet1,Kadota Richard1,Shen Violet1,Luchtman-Jones Lori1,Rytting Michael1,Bomgaars Lisa R.1,Rheingold Susan1,Ritchey Kim1,Albano Edythe1,Arceci Robert J.1,Goldman Stewart1,Griffin Timothy1,Altman Arnold1,Gordon Bruce1,Steinherz Laurel1,Weitman Steven1,Steinherz Peter1

Affiliation:

1. From the St Jude Children's Research Hospital, Memphis, TN; Children's Hospital of Los Angeles, Los Angeles; Children's Hospital of San Diego, San Diego; Children's Hospital of Orange County, Orange, CA; Washington University Medical School, St Louis, MO; M.D. Anderson Cancer Center, Houston; Texas Children's Cancer Center, Houston; Cook's Children's Hospital, Fort Worth; Genzyme Oncology, San Antonio, TX; The Children's Hospital of Philadelphia, Philadelphia; Children's Hospital of Pittsburgh,...

Abstract

Purpose To evaluate the efficacy and safety of clofarabine, a novel deoxyadenosine analog, in pediatric patients with refractory or relapsed acute lymphoblastic leukemia (ALL). Patients and Methods In a phase II, open-label, multicenter study, 61 pediatric patients with refractory or relapsed ALL received clofarabine 52 mg/m2 intravenously over 2 hours daily for 5 days, every 2 to 6 weeks. The median age was 12 years (range, 1 to 20 years), and the median number of prior regimens was three (range, two to six regimens). Results The response rate was 30%, consisting of seven complete remissions (CR), five CRs without platelet recovery (CRp), and six partial remissions. Remissions were durable enough to allow patients to proceed to hematopoietic stem-cell transplantation (HSCT) after clofarabine. Median CR duration in patients who did not receive HSCT was 6 weeks, with four patients maintaining CR or CRp for 8 weeks or more (8+, 12, 37+, and 48 weeks) on clofarabine therapy alone. The most common adverse events of grade ≥ 3 were febrile neutropenia, anorexia, hypotension, and nausea. Conclusion Clofarabine is active as a single agent in pediatric patients with multiple relapsed or refractory ALL. The toxicity profile is as expected in this heavily pretreated patient population. Studies exploring rational combinations of clofarabine with other agents are ongoing in an effort to maximize clinical benefit.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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