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Related Collections Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 15 May 2002, Vol. 99, No. 10, pp. 3554-3561 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study Michael J. Keating, Ian Flinn, Vinay Jain, Jacques-Louis Binet, Peter Hillmen, John Byrd, Maher Albitar, Lee Brettman, Pedro Santabarbara, Bret Wacker, and Kanti R. Rai From the M. D. Anderson Cancer Center, Houston, TX; Johns Hopkins Institute, Baltimore, MD; Texas Oncology P.A., Austin, TX; Hôpital Pitié Salpetrière, Paris, France; Leeds General Infirmary, Leeds, United Kingdom; Ohio State University, Columbus; Millennium Pharmaceuticals, Cambridge, MA; Ilex Oncology, San Antonio, TX; and Long Island Jewish Medical Center, New Hyde Park, NY. This study investigated the efficacy, safety, and clinical benefit of alemtuzumab (Campath-1H) for patients with relapsed or refractory B-cell chronic lymphocytic leukemia exposed to alkylating agents and having failed fludarabine therapy. Ninety-three patients received alemtuzumab in 21 centers worldwide, with the aim to obtain an overall response rate of at least 20%. Dosage was increased gradually (target 30 mg, 3 times weekly, for a maximum of 12 weeks). Infection prophylaxis was mandatory, beginning on day 8, and continuing for a minimum of 2 months after treatment. Responses were assessed at weeks 4, 8, and 12, and patients were followed for 34 months. Overall objective response in the intent-to-treat population (n = 93) was 33% (CR 2%, PR 31%). Median time to response was 1.5 months (range, 0.4-3.7 months). Median time to progression was 4.7 months overall, 9.5 months for responders. At data cut-off, 27 patients (29%) were alive; overall median survival was 16 months (95% CI: 11.8-21.9) and 32 months for responders. Nineteen responders survived more than 21 months. Clinical benefit was observed both in responders and in patients with stable disease. The most common adverse events were related to infusion, generally grade 1 or 2 in severity, occurring mainly in the first week. Grade 3 or 4 infections were reported in 25 patients (26.9%). However, only 3 (9.7%) of 31 patients who responded to alemtuzumab treatment developed grade 3 or 4 infections on the study. Alemtuzumab induced significant responses in these patients with clinical benefit in the majority and with acceptable toxicity in a high-risk group. © 2002 by The American Society of Hematology.   CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: M. A. Phelps, T. S. Lin, A. J. Johnson, E. Hurh, D. M. Rozewski, K. L. Farley, D. 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