Phase II study of clofarabine in pediatric patients with refractory or relapsed acute lymphoblastic leukemia Journal Article


Authors: Jeha, S.; Gaynon, P. S.; Razzouk, B. I.; Franklin, J.; Kadota, R.; Shen, V.; Litchtman-Jones, L.; Rytting, M.; Bomgaars, L. R.; Rheingold, S.; Ritchey, K.; Albano, E.; Arceci, R. J.; Goldman, S.; Griffin, T.; Altman, A.; Gordon, B.; Steinherz, L.; Weitman, S.; Steinherz, P.
Article Title: Phase II study of clofarabine in pediatric patients with refractory or relapsed acute lymphoblastic leukemia
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/m(2) 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.
Keywords: fludarabine; gemcitabine; experience; children; induction; high-dose cytarabine; oncology-group; lymphocytic-leukemia; 2-chloro-9-(2-deoxy-2-fluoro-beta-d-arabinofuranosyl)adenine; cytokine-release syndrome
Journal Title: Journal of Clinical Oncology
Volume: 24
Issue: 12
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2006-04-20
Start Page: 1917
End Page: 1923
Language: English
ACCESSION: WOS:000237124300022
DOI: 10.1200/jco.2005.03.8554
PROVIDER: wos
PUBMED: 16622268
Notes: --- - Article - "Source: Wos"
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  1. Peter G Steinherz
    162 Steinherz