PHASE II MULTICENTER STUDY OF NATALIZUMAB PLUS STANDARD STEROID TREATMENT FOR HIGH RISK ACUTE GRAFT-VERSUS-HOST DISEASE
A study for patients with acute graft host disease (GVHD) following bone marrow transplant using study drug Natalizumab
Sponsor: Icahn School of Medicine at Mount Sinai
Enrolling: Male and Female Patients
IRB Number: AAAQ8173
U.S. Govt. ID: NCT02133924
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the transplant recipient. Acute GVHD usually happens within the first several months after transplant. The goal of this research is to develop a safer and more effective treatment for acute GVHD, and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.
This study is closed
Investigator
Ran Reshef, MD
Do You Qualify?
Are you at least 18 years of age? Yes No
Have you recently undergone bone marrow transplantation? Yes No
Have you been diagnosed with GVHD? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162