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Prepublished online as a Blood First Edition Paper on June 5, 2003; DOI 10.1182/blood-2003-03-0925. This Article Full Text (PDF) All Versions of this Article: 2003-03-0925v1 102/7/2379    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Kantarjian, H. M Articles by Freireich, E. J Search for Related Content PubMed PubMed Citation Articles by Kantarjian, H. M Articles by Freireich, E. J Related Collections Related Article in Blood Online Social Bookmarking                   What's this? Submitted April 1, 2003 Accepted May 24, 2003 Phase II clinical and pharmacology study of clofarabine in patients with refractory or relapsed acute leukemia Hagop M Kantarjian*, Varsha Gandhi, Jorge Cortes, Srdan Verstovsek, Min Du, Guillermo Garcia-Manero, Francis Giles, Stefan Faderl, Susan O'Brien, Sima Jeha, Jan Davis, Zeev Shaked, Adam Craig, Michael Keating, William Plunkett, and Emil J Freireich Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA Experimental Therapeutics, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA ILEX Company, San Antonio, TX, USA Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA; Experimental Therapeutics, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA * Corresponding author; email: hkantarj{at}mdanderson.org. In a phase II study, 62 patients with relapsed and refractory acute myeloid leukemia (AML; N=31), myelodysplastic syndrome (MDS; N=8), chronic myeloid leukemia in blastic phase (CMLBP; N=11) and acute lymphocytic leukemia (ALL; N=12) received clofarabine 40 mg/m2 IV over 1 hour daily x 5, every 3 to 6 weeks. Twenty patients (32%) achieved complete response (CR), 1 had a partial response (PR), and 9 (15%) had CR but without platelet recovery (CR-p), for an overall response rate of 48%. In AML, responses were noted in 2/11 patients (18%) in first salvage with short first CR (12 months), in 7/8 (87%) patients with longer first CR, and in 8/12 patients (67%) in second or subsequent salvage. Responses were observed in 4/8 patients with high-risk MDS (50%), in 7/11 (64%) with CML-BP, and in 2/12 (17%) with ALL. Severe reversible liver dysfunction was noted in 15% to 25%. After the first clofarabine infusion, responders accumulated more clofarabine triphosphate in blasts compared to non-responders (median 18 vs 10 µM; p=0.03). This increased only in responders (median, 1.8-fold; p=0.008) after the second clofarabine infusion. In summary, clofarabine is active in acute leukemias and MDS; cellular pharmacokinetics may have prognostic significance. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: PNAs for AML Mark R. Litzow Blood 2003 102: 2315. [Full Text] [PDF] This article has been cited by other articles: C. Seedhouse, M. Grundy, S. Shang, J. Ronan, H. Pimblett, N. Russell, and M. Pallis Impaired S-Phase Arrest in Acute Myeloid Leukemia Cells with a FLT3 Internal Tandem Duplication Treated with Clofarabine Clin. Cancer Res., December 1, 2009; 15(23): 7291 - 7298. [Abstract] [Full Text] [PDF] S. Jeha, B. Razzouk, M. Rytting, S. Rheingold, E. Albano, R. Kadota, L. Luchtman-Jones, L. 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