Trial purpose
Cancer treatment
Tumor type
Haematological
Age
1 - 21
Clinical summary
Summary
This trial has two parts.
In Part A, patients that are ≥1 to <12 years of age and have moderate or severe chronic graft versus host disease (cGVHD), will receive oral ibrutinib once daily to determine the Recommended Pediatric Equivalent Dose (RPED). Patients in Part A of the trial may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED. Patients ≥1 to <12 years of age (upper age limit is < 22 years) and enrolled in Part B will receive ibrutinib at the RPED dose. Patients aged 12 and over will receive oral ibrutinib once daily at a 420mg dose.
Conditions
This trial is treating people with chronic Graft Versus Host Disease (cGVHD)
Eligibility
Inclusion
- 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
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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
- 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)
Inclusion
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Pharmacyclics LLC. & Janssen Research & Development, LLC.
Scientific Title
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
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