Phase III, open-label, randomized, multicenter efficacy and safety study of bendamustine hydrochloride [bendamustine; Treanda; Cephalon] versus chlorambucil in treatment-naive patients with (Binet stage B/C) chronic B-cell lymphocytic leukemia (B-CLL) requiring therapy.

Trial Profile

Phase III, open-label, randomized, multicenter efficacy and safety study of bendamustine hydrochloride [bendamustine; Treanda; Cephalon] versus chlorambucil in treatment-naive patients with (Binet stage B/C) chronic B-cell lymphocytic leukemia (B-CLL) requiring therapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2012

At a glance

  • Drugs Bendamustine (Primary) ; Chlorambucil
  • Indications B-cell leukaemia; Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Mundipharma International; Ribosepharm
  • Most Recent Events

    • 01 Oct 2012 Overall survival results (median of 54 months' follow-up) were published in the British Journal of Haematology.
    • 05 Dec 2010 Results presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH).
    • 08 Dec 2009 Results presented at the 51st Annual Meeting and Exposition of the American Society of Hematology.
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