Purpose

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

Condition

Eligibility

Eligible Ages
Between 1 Year and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy
  2. 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
  3. History of allogeneic stem cell transplantation
  4. Age
  5. Part A: ≥1 to <12 years of age at the time of enrollment
  6. Part B: ≥1 to <22 years of age at the time of enrollment
  7. Karnofsky or Lansky (subjects <16 years of age) performance status ≥60

Key Eligibility:

Exclusion Criteria

  1. Presence of single organ genito-urinary involvement as the only manifestation of cGVHD
  2. Received an investigational agent within 28 days before enrollment.
  3. Received donor lymphocyte infusion (DLI) within 56 days before enrollment
  4. Progressive underlying malignant disease or active post-transplant lymphoproliferative disease
  5. Any uncontrolled infection or active infection requiring ongoing systemic treatment
  6. Known bleeding disorders
  7. Active hepatitis C virus (HCV) or hepatitis B virus (HBV)

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1/2
Part A: Subjects ≥1 to <12 years of age with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, will receive oral ibrutinib once daily to determine Recommended Pediatric Equivalent Dose (RPED). Part A Continuation: Subjects participating in Part A may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED. Part B: Subjects ≥1 to <12 years of age( upper age limit is < 22 years) with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy or with newly diagnosed moderate or severe cGVHD will be dosed at the RPED. Subjects ≥12 will be given 420mg orally ibrutinib once daily.
  • Drug: Ibrutinib
    Ibrutinib capsule, tablet, or suspension administered orally once daily
    Other names:
    • IMBRUVICA®
    • PCI-32765

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010

More Details

NCT ID
NCT03790332
Status
Recruiting
Sponsor
Pharmacyclics LLC.

Study Contact

Alina Smith
408-215-3442
asmith@pcyc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.