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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)
Not Recruiting
Trial ID: NCT02959944
Purpose
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects
with newly diagnosed moderate to severe cGVHD.
Official Title
A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)
Stanford Investigator(s)
David Miklos
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lori Muffly
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng, MD, PhD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
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)
Intervention(s):
drug: ibrutinib
drug: Placebo
drug: Prednisone
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061