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Blood, 15 June 2007, Vol. 109, No. 12, pp. 5136-5142.
Prepublished online as a Blood First Edition Paper on March 7, 2007; DOI 10.1182/blood-2006-11-056754.
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Submitted November 13, 2006
Accepted February 13, 2007
Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: cancer and leukemia group B study 19801
Daniel J DeAngelo*, Daohai Yu, Jeffrey L. Johnson, Steven E. Coutre, Richard M. Stone, Alison T. Stopeck, Jon P. Gockerman, Beverly S. Mitchell, Frederick R. Appelbaum, and Richard A. Larson
Dept of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States
CALGB Statistical Center, Duke University Medical Center, Durham, NC, United States
Stanford University School of Medicine, Stanford, CA, United States
Arizona Cancer Center, Tucson, AZ, United States
Duke University Medical center, Durham, NC, United States
University of North Carolina, Chapel Hill, NC, United States
Fred Hutchinson Cancer Research Center, Seattle, WA, United States
University of Chicago, Chicago, IL, United States
* Corresponding author; email: ddeangelo{at}partners.org.
Nelarabine (506U78) is a soluble pro-drug of 9- -D-arabinofuranosylguanine (ara-G), a deoxyguanosine derivative. We treated 26 patients with T-cell acute lymphoblastic leukemia (T-ALL) and 13 with T-cell lymphoblastic lymphoma (T-LBL) with nelarabine. All patients were refractory to at least one multi-agent regimen or had relapsed after achieving a complete remission. Nelarabine was administered on an alternate day schedule (days 1, 3, 5) at 1.5 g/m2/day. Cycles were repeated every 22 days. The median age was 34 years (range, 16-66); 32 (82%) patients were male. The rate of complete remission was 31% (95% CI: 17%, 48%) and the overall response rate was 41% (95% CI: 26%, 58%). The principal toxicity was grade 3 or 4 neutropenia and thrombocytopenia, occurring in 37% and 26% of patients, respectively. There was only one grade 4 adverse event of the nervous system, which was a reversible depressed level of consciousness. The median disease free survival (DFS) was 20 weeks (95% CI: 11, 56) and the median overall survival was 20 weeks (95% CI: 13, 36). The one-year overall survival was 28% (95% CI: 15%, 43%). Nelarabine is well tolerated, and has significant anti-tumor activity in relapsed or refractory T-ALL and T-LBL.

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