Graft-vs-host disease (GVHD) remains the major complication of allogeneic bone marrow transplantation (BMT). Research in several laboratories, including that of the principal investigator, have demonstrated that the inflammatory cytokine Interleukin-1 (IL-1) is an important effector molecule of GVHD providing a new opportunity for additional prophylaxis against this complication. This study will test the hypothesis that the interruption of the inflammatory cytokine cascade can lead to a reduced incidence and severity of clinical GVHD after allogeneic BMT.
Specific Aims : 1) Perform a randomized trial of IL-1 receptor antagonist (IL-1ra) vs. placebo plus standard GVHD prophylaxis (methotrexate and cyclosporine) in order to reduce the incidence and severity of significant acute GVHD (Grades B-D) after allogeneic bone marrow transplantation 2) Evaluate levels of inflammatory cytokines (IL-1, TNF-a), their antagonists (IL-1ra, sTNFR) and cofactors endotoxin or lipopolysaccharide (LPS) as surrogate markers for acute GVHD and other transplant related toxicities during the course of the study

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR002172-17S2
Application #
6220603
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
17
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Children's Hospital Boston
Department
Type
DUNS #
076593722
City
Boston
State
MA
Country
United States
Zip Code
02115
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