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

Completed · Phase 1/Phase 2

Conditions studied: Chronic Graft Versus Host Disease

In brief

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

Key facts

Study ID

NCT03790332

Run by

Pharmacyclics LLC.

People needed

59

Starts

2018-11-19

Expected to finish

2025-10-09

Last updated by the study team

2025-10-21

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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)

Where it is running

• City of Hope — Duarte, California, United States
• Rady Children's Hospital — San Diego, California, United States
• University of California — San Francisco, California, United States
• Children's Hospital — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Cancer Center for Children. The Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Queensland Children's Hospital — South Brisbane, Queensland, Australia
• The Royal Children's Hospital — Parkville, Victoria, Australia
• Sydney Children's Hospital — Randwick, Australia
• St. Anna Kinderspital — Vienna, Austria

Full record on ClinicalTrials.gov

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