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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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Submitted February 16, 2005
Accepted July 5, 2005
Thalidomide in combination with fludarabine as initial therapy for patients with treatment-requiring chronic lymphocytic leukemia (CLL). Results of a phase I clinical trial
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
Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA
Department of Radiology, Roswell Park Cancer Institute, Buffalo, NY, USA
Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, NY, USA
Department of Pathology, Roswell Park Cancer Institute, Buffalo, NY, USA
Division of Hematology, New York University, New York, NY, USA
Celgene Corporation, NJ, USA
* Corresponding author; email: asher.chanan-khan{at}roswellpark.org.
TNF- and VEGF play an important role in the biology of CLL cells. Thalidomide is a first generation immunomodulating agent that down regulates TNF and VEGF. We initiated a phase I/II clinical trial to determine the safety and efficacy of combining thalidomide with fludarabine in patients with treatment-naive CLL. Patients received 6 months of continuous daily thalidomide with standard monthly doses of fludarabine. Three dose levels of thalidomide (100,200 and 300mg) were studied. Results from the Phase I part of this study are reported here. Thirteen patients were enrolled on the phase I component of the study. Dose-limiting toxicity was not reached. The most common toxicity noted was fatigue, constipation and peripheral sensory neuropathy. Overall response rate was 100% with 55% of patients achieving a complete remissions. At a median follow-up of 15+ months none of the patients have relapsed and median time to disease progression has not yet been reached. Responses were noted at all dose levels. Thalidomide given up to 300mg per day, concurrently with fludarabine in patients with previously untreated CLL shows encouraging clinical efficacy and acceptable toxicity. An ongoing phase II part of this study will help validate the clinical efficacy of this regimen.
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