The Addition of Etanercept to Standard GVHD Prophylaxis in Patients Undergoing a Full Intensity Allogeneic Hematopoietic Stem Cell Transplant for the Prevention of Transplant Related Complications
This is a clinical trial to see if the addition of etanercept helps in preventing two major
complications of hematopoietic stem cell transplantation (HSCT). The main objective will be
to see whether the addition of etanercept to standard preventative medicines will decrease
the rate of acute graft-vs-host disease (GVHD) and the risk of death by 100 days following
allogeneic HSCT from volunteer donors.
GVHD is a common complication following a bone marrow transplant from another donor. GVHD
occurs after transplant when the donor's blood cells recognize parts of the body as foreign.
During this process, chemicals called cytokines are released that may damage certain body
tissues, including the gut, liver and skin. Some of the main effects can include red skin
rash, diarrhea, sometimes with blood, and yellow jaundice. It can range from mild to life
threatening and often requires admission to the hospital for treatment. The standard
treatment for acute GVHD is a combination of steroids and another drug that suppress the
immune system, such as tacrolimus or cyclosporine.
Etanercept is a drug that blocks a chemical called Tumor Necrosis Factor (TNF) from causing
damage to your tissue. The purpose of etanercept is to help improve the response to
standard treatment for GVHD. Previous studies have shown that less than 50% of patients
respond fully to GVHD treatment. Without a good response, patients often have a prolonged
treatment for this disease, often involving hospitalization and sometimes even death.
Etanercept (Enbrel) will be added to the standard treatment to see if we can lower the rate
of GVHD and the risk of death from GVHD by blocking TNF.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether etanercept given prophylactically, along with a standard GVHD prevention regimen, will decrease the 100-day mortality and the rate of acute GVHD after allogeneic hematopoietic stem cell transplantation(HSCT)
John E. Levine, MD, MS
The University of Michigan Comprehensive Cancer Center
United States: Institutional Review Board
|The University of Michigan||Ann Arbor, Michigan 48109|
|Loyola University Medical Center, Cardinal Bernardin Cancer Center||Maywood, Illinois 60153|