CompletedPhase 1/2

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

United States59 participantsStarted 2018-11-19

Plain-language summary

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

Age range1 Year – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Karnofsky or Lansky (subjects \<16 years of age) performance status ≥60

✕. 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)

Part A- PK (measured by AUC) will be reported descriptively

Timeframe: Approximately 24 months

Part B- PK (measured by AUC) will be reported descriptively

Timeframe: Approximately 7 years

Number of patients with adverse events as a measure of safety and tolerability

Timeframe: Approximately 7 years

NCT IDNCT03790332

SponsorPharmacyclics LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-09

Who can participate

Age range1 Year – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Karnofsky or Lansky (subjects \<16 years of age) performance status ≥60

✕. 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)