Education and Training
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: ibrutinib
- drug: Placebo
- drug: Prednisone
Eligibility
Key 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)
Ages Eligible for Study
12 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting