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Prepublished online as a Blood First Edition Paper on July 12, 2002; DOI 10.1182/blood-2002-03-0972. This Article Full Text (PDF) All Versions of this Article: 2002-03-0972v1 100/9/3115    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Schulz, H. Articles by Engert, A Search for Related Content PubMed PubMed Citation Articles by Schulz, H. Articles by Engert, A Social Bookmarking                   What's this? Submitted April 16, 2002 Accepted June 11, 2002 Phase-II Study of a combined Immuno-Chemotherapy using Rituximab and Fludarabine in Patients With Chronic Lymphocytic Leukemia Holger Schulz*, S K Klein, U Rehwald, M Reiser, A Hinke, W Knauf, W E Aulitzky, M Hensel, M Herold, D Huhn, M Hallek, V Diehl, and A Engert Clinic I of Internal Medicine, University of Cologne, Cologne, Germany WiSP Research, Langenfeld, Germany Med. Clinic III, Hematology, Oncology and Transfusion Medicine, Universitaetsklinikum Benjamin Franklin, Berlin, Germany Center of Internal Medicine, Robert-Bosch-Krankenhaus, Stuttgart, Germany Dep. of Medicine V, Hematology/Rheumatology/Oncology, Ruprecht-Karls-University, Heidelberg, Germany 2. Medical Clinic Hematology/Oncology, Klinikum Erfurt GmbH, Erfurt, Germany Department of Medicine Hematology/Oncology, Charite Campus Virchow Klinikum, Berlin, Germany German CLL Study Group, Munich, Germany * Corresponding author; email: Holger.Schulz{at}uni-koeln.de. This multicenter phase-II trial investigated safety and efficacy of a new immuno-chemotherapeutic regimen combining rituximab (R) and fludarabine (F) in patients with fludarabine and anthracycline-naive chronic lymphocytic leukemia (CLL). The rationale for using R + F includes single agent efficacy of both drugs, in vitro synergism of R and F, and no apparent overlapping toxicity. Of 31 eligible B-CLL patients enrolled, 20 were previously untreated and 11 relapsed. Treatment consisted of fludarabine administered at standard doses (25mg/m2/d; days 1-5, 29-33, 57-61, 85-89) and rituximab (375mg/m2/d) given on days 57, 85, 113 and 151. Side effects such as fever, chills, and exanthema were generally mild (NCI-CTC grade I/II in 48% and grade III/IV in 3% of pts). Fever and chills were mainly associated with the first rituximab infusion. Hematological toxicity included neutropenia (grade I-II in 26%, grade III-IV in 42%) and thrombocytopenia (grade I-II in 19%, grade III-IV in 9%). One patient died of cerebral bleeding during prolonged thrombocytopenia after the second cycle of fludarabine. There were a total of 32 infections in 16 patients, none of which was fatal. The overall response rate (CR and PR) was 87% (27/31 evaluable patients). In 20 previously untreated pts, 17 responded (85%). 10/31 pts achieved CR (5/20 untreated; 5/11 pretreated; 9/21 Binet stage B, 1/10 Binet stage C). The median duration of response was 75 weeks. We conclude that the combination of rituximab and fludarabine is feasible and effective in patients with B-CLL. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: J. M. Flynn and J. C. Byrd Have We Forgotten the Purpose of Phase III Studies? J. Clin. Oncol., December 10, 2007; 25(35): 5553 - 5555. [Full Text] [PDF] G. Ungerechts, C. Springfeld, M. E. Frenzke, J. Lampe, P. B. Johnston, W. B. Parker, E. J. Sorscher, and R. 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