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

Trial Status: Active

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

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

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)

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Boston Children's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Tennessee

Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE

Utah

Salt Lake City
Primary Children's Hospital
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Pharmacyclics LLC.

  • Primary ID PCYC-1146-IM
  • Secondary IDs NCI-2019-00045
  • Clinicaltrials.gov ID NCT03790332