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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2026
  • participants needed
    44
  • sponsor
    Pharmacyclics LLC.
Updated on 24 January 2021
Investigator
Alina Smith
Primary Contact
The Royal Children's Hospital (3.2 mi away) Contact
+49 other location
cell transplantation
immunosuppression
ibrutinib

Summary

Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

Details
Condition Chronic Graft Versus Host Disease, chronic graft-versus-host disease
Treatment Ibrutinib
Clinical Study IdentifierNCT03790332
SponsorPharmacyclics LLC.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy
Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of systemic immunosuppression
History of allogeneic stem cell transplantation
Age
Part A: 1 to <12 years of age at the time of enrollment
Part B: 1 to <22 years of age at the time of enrollment
Karnofsky or Lansky (subjects <16 years of age) performance status 60
Key Eligibility

Exclusion Criteria

Presence of single organ genito-urinary involvement as the only manifestation of cGVHD
Received an investigational agent within 28 days before enrollment
Received donor lymphocyte infusion (DLI) within 56 days before enrollment
Progressive underlying malignant disease or active post-transplant lymphoproliferative disease
Any uncontrolled infection or active infection requiring ongoing systemic treatment
Known bleeding disorders
Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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