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A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)

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Trial Profile

A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jan 2023

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At a glance

  • Drugs Ibrutinib (Primary) ; Prednisone
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms iNTEGRATE
  • Sponsors Janssen Pharmaceutical KK; Pharmacyclics

    • Most Recent Events

    • 06 Jan 2023 Primary endpoint (Final Analysis: Response Rate at 48 Weeks) has not been met, according to Results published in the Journal of Clinical Oncology.
    • 06 Jan 2023 Results published in the Journal of Clinical Oncology
    • 11 Jan 2022 Results published in the European Clinical Trials Database Trial Registry

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