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Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton s Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Trial Profile

Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton s Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2022

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At a glance

  • Drugs Ibrutinib (Primary) ; Bendamustine; Rituximab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms HELIOS
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 05 Jun 2019 This trial has been completed in Spain, according to European Clinical Trials Database.
    • 19 Mar 2019 Status changed from active, no longer recruiting to completed.
    • 10 Feb 2019 This trial was completed in Belgium, according to European Clinical Trials Database.

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