Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: A randomised, open-label, phase 3 trial

M. Hallek, K. Fischer, G. Fingerle-Rowson, A. M. Fink, R. Busch, J. Mayer, M. Hensel, G. Hopfinger, G. Hess, U. Von Grünhagen, M. Bergmann, J. Catalano, P. L. Zinzani, F. Caligaris-Cappio, J. F. Seymour, A. Berrebi, U. Jäger, B. Cazin, M. Trneny, A. WestermannC. M. Wendtner, B. F. Eichhorst, P. Staib, A. Bühler, D. Winkler, T. Zenz, S. Böttcher, M. Ritgen, M. Mendila, M. Kneba, H. Döhner, S. Stilgenbauer

Research output: Contribution to journalArticle

Abstract

Background On the basis of promising results that were reported in several phase 2 trials, we investigated whether the addition of the monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve the outcome of patients with chronic lymphocytic leukaemia. Methods Treatment-naive, physically fit patients (aged 30-81 years) with CD20-positive chronic lymphocytic leukaemia were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine (25 mg/m2 per day) and cyclophosphamide (250 mg/m2 per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m2 on day 0 of first course, and 500 mg/m2 on day 1 of second to sixth courses) in 190 centres in 11 countries. Investigators and patients were not masked to the computer-generated treatment assignment. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00281918. Findings 408 patients were assigned to fludarabine, cyclophosphamide, and rituximab (chemoimmunotherapy group) and 409 to fludarabine and cyclophosphamide (chemotherapy group); all patients were analysed. At 3 years after randomisation, 65 of patients in the chemoimmunotherapy group were free of progression compared with 45 in the chemotherapy group (hazard ratio 0·56 [95 CI 0·46-0·69], p

Original languageEnglish
Pages (from-to)1164-1174
Number of pages11
JournalLancet
Volume376
Issue number9747
DOIs
Publication statusPublished - Oct 2 2010

ASJC Scopus subject areas

  • Medicine(all)

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    Hallek, M., Fischer, K., Fingerle-Rowson, G., Fink, A. M., Busch, R., Mayer, J., Hensel, M., Hopfinger, G., Hess, G., Von Grünhagen, U., Bergmann, M., Catalano, J., Zinzani, P. L., Caligaris-Cappio, F., Seymour, J. F., Berrebi, A., Jäger, U., Cazin, B., Trneny, M., ... Stilgenbauer, S. (2010). Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: A randomised, open-label, phase 3 trial. Lancet, 376(9747), 1164-1174. https://doi.org/10.1016/S0140-6736(10)61381-5