A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2017

At a glance

  • Drugs Idelalisib (Primary) ; Bendamustine; Rituximab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms Tugela
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 27 Jan 2017 A per the interim analysis of June 15, 2015 the independent data monitoring committee recommended halting and unblinding the study on the basis of the high efficacy of idelalisib.
    • 27 Jan 2017 Results of interim analysis (Data cut off, 7 Oct. 2015), published in the Lancet Oncology
    • 06 Dec 2016 Results (data cut off,May 2016) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
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