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

Trial ID or NCT#

NCT02959944

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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)
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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lori Muffly
Lori Muffly
Hematologist, Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Robert Negrin
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov