Status:
COMPLETED
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
Lead Sponsor:
Pharmacyclics LLC.
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
PHASE2
Brief Summary
Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
Eligibility Criteria
Inclusion
- Key Eligibility:
- 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
- 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)
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2025
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03790332
Start Date
November 19 2018
End Date
October 9 2025
Last Update
October 21 2025
Active Locations (48)
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1
City of Hope
Duarte, California, United States, 91010
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
University of California
San Francisco, California, United States, 94158
4
Children's Hospital
Aurora, Colorado, United States, 80045