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A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Rituximab as Therapy for Patients with Previously Treated Chronic Lymphocytic Leukemia

Trial Profile

A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Rituximab as Therapy for Patients with Previously Treated Chronic Lymphocytic Leukemia

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2018

At a glance

  • Drugs Idelalisib (Primary) ; Rituximab
  • Indications Chronic lymphocytic leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Most Recent Events

    • 04 Dec 2018 Results evaluating the impact of IDELA treatment interruption on duration of IDELA therapy (DoT), progression-free survival (PFS), and overall survival (OS) from 101-09, 312-0116/0117, 312-0119 ( NCT01282424, NCT01659021,NCT01539291,NCRN389 ) , presented at the 60th Annual Meeting and Exposition of the American Society of Hematology.
    • 14 May 2014 Status changed from recruiting to active, no longer recruiting as reported by United Kingdom Clinical Research Network record.
    • 25 Feb 2013 New trial record
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