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Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

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Trial Profile

Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 16 Jul 2024

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At a glance

  • Drugs Ibrutinib (Primary)
  • Indications Graft-versus-host disease
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms iMAGINE
  • Sponsors Pharmacyclics

Most Recent Events

  • 01 Nov 2022 primary Results published in the Transplantation and Cellular Therapy
  • 24 Aug 2022 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy, based on data from this study.
  • 28 Feb 2022 According to an AbbVie media release, the company announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for ibrutinib for the treatment of pediatric and adolescent patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic therapy. Based on data from this study.

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