Originally published as JCO Early Release 10.1200/JCO.2005.01.9950 on September 6 2005

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Fludarabine in Combination With Alemtuzumab Is Effective and Feasible in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia: Results of a Phase II Trial

From the Department of Hematology and Oncology; Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne; Department of Hematology and Oncology, University of Erlangen, Erlangen; Department of Hematology and Oncology, University of Kiel, Kiel; Department of Hematology, Robert-Bosch-Hospital, Stuttgart; and Outpatient Center for Hematology and Oncology, Siegburg, Germany

Address reprint requests to Andreas Engert, MD, PhD, First Department of Internal Medicine, Joseph-Stelzmann-Str 9, 50924 Cologne, Germany; e-mail: a.engert{at}uni-koeln.de

PURPOSE: To determine the efficacy and safety of a newly developed concomitant administration of fludarabine and alemtuzumab (FluCam) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL).

PATIENTS AND METHODS: A total of 36 patients were treated in this phase II study (median age, 61.47 years; mean number of prior chemotherapies, 2.6; Binet stage C, n = 28). After an initial dose escalation of alemtuzumab over 3 days, alemtuzumab 30 mg and fludarabine 30 mg/m² were administered on 3 consecutive days. Treatment was repeated after 28 days for up to six cycles. Restaging (following National Cancer Institute criteria) was carried out after cycles 2 and 4 and 1 month after the end of treatment.

RESULTS: The overall response rate was 83% (11 complete responses, 19 partial responses, one stable disease, and five progressive diseases). Two patients with progressive disease developed fungal pneumonias, and one patient died as a result of Escherichia coli sepsis. Two subclinical cytomegalovirus reactivations occurred.

CONCLUSION: The new FluCam regimen is effective and feasible in patients with relapsed and refractory B-CLL.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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