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Prepublished online as a Blood First Edition Paper on July 12, 2002; DOI 10.1182/blood-2002-03-0972.
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Blood, 1 November 2002, Vol. 100, No. 9, pp. 3115-3120
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Phase 2 study of a combined immunochemotherapy using
rituximab and fludarabine in patients with chronic lymphocytic
leukemia
Holger Schulz,
Saskia
Karina Klein,
Ute Rehwald,
Marcel Reiser,
Axel Hinke,
Wolfgang-Ulrich Knauf,
Walter-Erich Aulitzky,
Manfred Hensel,
Michael Herold,
Dieter Huhn,
Michael Hallek,
Volker Diehl, and
Andreas Engert on behalf of the German CLL Study Group
(GCLLSG)
From the Clinic I of Internal Medicine, University of
Cologne, Cologne, Germany; WiSP Research, Langenfeld, Germany; Medical
Clinic III Hematology, Oncology and Transfusion Medicine,
Universitätsklinikum Benjamin Franklin, Berlin, Germany; Center
of Internal Medicine, Robert-Bosch-Krankenhaus, Stuttgart, Germany;
Department of Medicine V, Hematology/Rheumatology/Oncology,
Ruprecht-Karls-University, Heidelberg, Germany; Medical Clinic,
Hematology/Oncology, Klinikum Erfurt GmbH, Erfurt, Germany; Department
of Medicine/Hematology and Oncology, Charité Campus Virchow
Klinikum, Berlin, Germany; and the German CLL Study Group, Munich,
Germany.
This multicenter phase 2 trial investigated safety and efficacy of
a new immunochemotherapeutic 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 patients
with B-CLL enrolled, 20 were previously untreated and 11 relapsed.
Treatment consisted of fludarabine administered at standard doses (25 mg/m2/d; days 1-5, 29-33, 57-61, and 85-89) and rituximab
(375 mg/m2/d) given on days 57, 85, 113, and 151. Side
effects such as fever, chills, and exanthema were generally mild
(National Cancer Institute Common Toxicity Criteria [NCI-CTC]
grade 1/2 in 48% and grade 3 and/or 4 in 3% of
patients). Fever and chills were mainly associated with the first
rituximab infusion. Hematologic toxicity included neutropenia (grade 1 and/or 2 in 26%, grade 3 and/or 4 in 42%) and
thrombocytopenia (grade 1 and/or 2 in 19%, grade 3 and/or 4 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 (complete remission [CR] and partial
remission [PR]) was 87% (27 of 31 evaluable patients). In 20 previously untreated patients, 17 (85%) responded. Ten of 31 patients
achieved CR (5 of 20 untreated; 5 of 11 pretreated; 9 of 21 Binet stage
B, 1 of 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.
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