About: Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial.     Goto   Sponge   Distinct   Permalink

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  • 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. 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/m(2) per day) and cyclophosphamide (250 mg/m(2) per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m(2) on day 0 of first course, and 500 mg/m(2) 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.
  • 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. 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/m(2) per day) and cyclophosphamide (250 mg/m(2) per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m(2) on day 0 of first course, and 500 mg/m(2) 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. (en)
Title
  • Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial.
  • Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. (en)
skos:prefLabel
  • Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial.
  • Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. (en)
skos:notation
  • RIV/00216224:14110/10:00051497!RIV12-MSM-14110___
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • I, V, Z(MSM0021620808)
http://linked.open...iv/cisloPeriodika
  • 9747
http://linked.open...vai/riv/dodaniDat
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  • 245421
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  • RIV/00216224:14110/10:00051497
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  • STEM-CELL TRANSPLANTATION; PROGRESSION-FREE SURVIVAL; PLUS CYCLOPHOSPHAMIDE; CYTOKINE-RELEASE; INITIAL THERAPY; III TRIAL; CHEMOIMMUNOTHERAPY; EXPRESSION; LYMPHOMA; DELETION (en)
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  • US - Spojené státy americké
http://linked.open...ontrolniKodProRIV
  • [2F3062F7C97F]
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  • Lancet
http://linked.open...in/vavai/riv/obor
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http://linked.open...v/svazekPeriodika
  • 376
http://linked.open...iv/tvurceVysledku
  • Jäger, U.
  • Mayer, Jiří
  • Zinzani, P. L.
  • Busch, R.
  • Eichhorst, B. F.
  • Fink, A. M.
  • Fischer, K.
  • Hallek, M.
  • Hopfinger, G.
  • Ritgen, M.
  • Stilgenbauer, S.
  • Wendtner, C. M.
  • Boettcher, S.
  • Kneba, M.
  • Zenz, T.
  • Bergmann, N.
  • Berrebi, A.
  • Buehler, A.
  • Caligaris-Cappio, F.
  • Catalano, J.
  • Cazin, B.
  • Doehner, H.
  • Fingerle-Rowson, G.
  • Hensel, M.
  • Hess, G.
  • Mendila, M.
  • Seymour, J. F.
  • Staib, P.
  • Trneny, M.
  • Westermann, A.
  • Winkler, D.
  • von Grünhagen, U.
http://linked.open...ain/vavai/riv/wos
  • 000282915700033
http://linked.open...n/vavai/riv/zamer
issn
  • 0140-6736
number of pages
http://bibframe.org/vocab/doi
  • 10.1016/S0140-6736(10)61381-5
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  • 14110
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