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Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
Trial Status: complete
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in
subjects with newly diagnosed moderate to severe cGVHD.
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 Key
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)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02959944.
Locations matching your search criteria
United States
Georgia
Atlanta
Children's Healthcare of Atlanta - Arthur M Blank Hospital
