Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

Study Identifier
PCYC-1140-IM
CT.gov Identifier
NCT02959944
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English, French, German, Italian, Japanese, Korean
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Immune & Inflammatory - Other
    • Study Drug
  • ibrutinib
  • Placebo
  • Prednisone
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * New onset moderate or severe cGVHD as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project Criteria * Need for systemic treatment with corticosteroids for cGVHD * No previous systemic treatment for cGVHD (including extracorporeal photopheresis \[ECP\]) * Participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d * Age ≥12 years old * Karnofsky or Lansky (subjects \<16 years) performance status ≥60
    Exclusion Criteria:
    * Received any previous systemic treatment for cGVHD with the exception of corticosteroids administered for cGVHD within the 72 hours prior to signing the informed consent form. * Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD * Any uncontrolled infection or active infection requiring ongoing systemic treatment * Progressive underlying malignant disease or any post-transplant lymphoproliferative disease * Known bleeding disorders * Active hepatitis C virus (HCV) or hepatitis B virus (HBV)

    Protocol Summary

    To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

    Study Locations

    Location
    Status
    Location
    Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120
    Scottsdale, Arizona, United States, 85258-4547
    Status
    Not applicable
    Location
    LPCH Stanford /ID# 1140-1128
    Palo Alto, California, United States, 94304
    Status
    Not applicable
    Location
    Ucsf /Id# 1140-0003
    San Francisco, California, United States, 94143
    Status
    Not applicable
    Location
    Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400
    Stanford, California, United States, 94305
    Status
    Not applicable
    Location
    UCHSC Anschultz Cancer Pavilion /ID# 1140-0068
    Aurora, Colorado, United States, 80010
    Status
    Not applicable
    Location
    Children's National Medical Center /ID# 1140-1122
    Washington D.C., District of Columbia, United States, 20010
    Status
    Not applicable
    Showing {first} - {last} of {total} Results