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 Thomas Elter, Peter Borchmann, Holger Schulz, Marcel Reiser, Sven Trelle, Roland Schnell, Markus Jensen, Peter Staib, Timo Schinköthe, Hartmut Stu ¨tzer, Ju ¨rgen Rech, Martin Gramatzki, Walter Aulitzky, Ibrahim Hasan, Andreas Josting, Michael Hallek, and Andreas Engert A B S T R A C T 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/m 2 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. J Clin Oncol 23:7024-7031. © 2005 by American Society of Clinical Oncology INTRODUCTION B-cell chronic lymphocytic leukemia (B-CLL) is the most common leukemia in North America and Europe, and its prevalence is increasing with the increasing average age of Western populations. 1 Treatment decisions are hindered by the difficulty in distinguish- ing between patients who will not require treatment and for whom a watchful waiting strategy might be appropriate and patients in whom the disease will progress and who require a more aggressive treatment. 2 Al- though B-CLL is currently incurable, recent developments are gradually making an impact on the natural history of the disease. These include promising new treatment options us- ing highly active agents. Fludarabine is one of the most effective agents for patients with B-CLL, with overall response (OR) rates of 50% to 60% in pre- viously treated patients 3,4 and 60% to 80% in previously untreated patients. 4-6 When evaluated in prospectively randomized tri- als, fludarabine has achieved significantly higher rates of complete response (CR) and From the Department of Hematology and Oncology; Institute of Medical Statistics, Informatics and Epidemiol- ogy, University of Cologne, Cologne; Department of Hematology and Oncol- ogy, University of Erlangen, Erlangen; Department of Hematology and Oncol- ogy, University of Kiel, Kiel; Department of Hematology, Robert-Bosch-Hospital, Stuttgart; and Outpatient Center for Hematology and Oncology, Siegburg, Germany. Submitted March 24, 2005; accepted June 6, 2005. Authors’ disclosures of potential con- flicts of interest are found at the end of this article. Address reprint requests to Andreas Engert, MD, PhD, First Department of Internal Medicine, Joseph-Stelzmann- Str 9, 50924 Cologne, Germany; e-mail: a.engert@uni-koeln.de. © 2005 by American Society of Clinical Oncology 0732-183X/05/2328-7024/$20.00 DOI: 10.1200/JCO.2005.01.9950 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T VOLUME 23  NUMBER 28  OCTOBER 1 2005 7024 Downloaded from jco.ascopubs.org on February 29, 2016. For personal use only. No other uses without permission. Copyright © 2005 American Society of Clinical Oncology. All rights reserved.