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Blood, 15 November 2005, Vol. 106, No. 10, pp. 3348-3352.
Prepublished online as a Blood First Edition Paper on July 28, 2005; DOI 10.1182/blood-2005-02-0669.
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CLINICAL TRIALS AND OBSERVATIONS
Results of a phase 1 clinical trial of thalidomide in combination with fludarabine as initial therapy for patients with treatment-requiring chronic lymphocytic leukemia (CLL)
Asher Chanan-Khan,
Kena C. Miller,
Kenichi Takeshita,
Alexandra Koryzna,
Kathleen Donohue,
Zale P. Bernstein,
Alice Mohr,
Donald Klippenstein,
Paul Wallace,
Jerome B. Zeldis,
Christine Berger, and
Myron S. Czuczman
From the Departments of Medicine, Health Behavior, Radiology, and Pathology, Roswell Park Cancer Institute, Buffalo, NY; Division of Hematology, New York University, New York, NY; and Celgene Corporation, Summit, NJ.
Tumor necrosis factor  (TNF-) and vascular endothelial growth factor (VEGF) play an important role in the biology of chronic lymphocytic leukemia (CLL) cells. Thalidomide is a first-generation immuno-modulating agent that down-regulates TNF- and VEGF. We initiated a phase 1/2 clinical trial to determine the safety and efficacy of combining thalidomide with fludarabine in patients with treatment-naïve CLL. Patients received 6 months of continuous daily thalidomide with standard monthly doses of fludarabine. Three dose levels of thalidomide (100, 200, and 300 mg) were studied. Results from the phase 1 part of this study are reported here. Thirteen patients were enrolled in the phase 1 component of the study. Dose-limiting toxicity was not reached. The most common toxicities noted were fatigue, constipation, and peripheral sensory neuropathy. Overall response rate was 100% with 55% of patients achieving complete remissions. At a median follow-up of 15+ months none of the patients have had a relapse and the median time to disease progression has not yet been reached. Responses were noted at all dose levels. Thalidomide given up to 300 mg/day concurrently with fludarabine in patients with previously untreated CLL shows encouraging clinical efficacy and acceptable toxicity. An ongoing phase 2 part of this study will help validate the clinical efficacy of this regimen.
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