Trial ID or NCT#

NCT02959944

Status

RECRUITING

Purpose

Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or hematopoietic cell transplant from another person (allogeneic transplant). Other than steroids, no other therapy has been shown in randomized controlled trials to be effective in cGVHD. Chronic GVHD is the major problem of allogeneic transplantation and new therapies are desparately needed. This study will determine if subjects with new onset cGVHD can tolerate ibrutinib and whether their cGVHD responds to ibrutinib in combination with corticosteroids.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

David Miklos, M.D., Ph.D.
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center
Laura Johnston, MD
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Associate Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center
Robert Negrin, M.D.
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation)
Robert Lowsky, MD
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center
Lori Muffly, MD, MS
Hematologist, Blood and marrow transplant specialist
Clinical Assistant Professor, Medicine - Blood & Marrow Transplantation

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

CONTACT

Janet McDowell
(650) 725-1647