THE FRED HUTCHINSON CANCER RESEARCH CENTER 
AND THE UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE 
DEPARTMENT OF MEDICINE, DIVISION OF ONCOLOGY 
Consent to Participate in the Use of Cyclosporine for the Prevention of Graft-Versus-Host Disease after 
Bone Marrow Transplantation 
Investigators: S.R. Riddell, M.D., Assistant Member, FHCRC, 667-5249; P.D. Greenberg, M.D., Professor 
of Medicine and Immunology UW, Member FHCRC; R.W. Overell, Ph.D., Immunex Corporation; T.P. 
Loughran, M.D., Associate Member FHCRC; M.J. Gilbert, M.D., Senior Fellow, FHCRC; S.D. Lupton, 
Ph.D., Immunex Corporation; J.M. Agosti, M.D., Immunex Corporation, S. Scheeler, Immunex 
Corporation, R.W. Coombs, M.D., Assistant Professor of Medicine, UW; L. Corey, M.D., Professor of 
Medicine, UW. 
24 hour phone: 667-5001 
Attending physician: Phone: 
BACKGROUND AND PURPOSE 
Graft-versus-host disease (GVHD) is a disease which is due to an immune reaction of donor cells against 
patient tissue cells. This disease develops after bone marrow transplantation. Many organs of the body (skin, 
eyes, mouth, hair, liver, esophagus, joints and bowel) may be damaged by this disease. Without treatment, 
most patients develop recurrent infections which may become fatal. Those who survive may be severely 
disabled from progressive hardening of the skin, contractures of the joints, drying of the eyes and weight 
loss. 
The drug cyclosporine is given after marrow transplantation in an attempt to prevent or reduce the severity of 
GVHD. This drug suppresses the immune system. There is some evidence from other transplantation 
situations in both animals and humans that treatment with drugs which suppress the patient’s immune system 
may prevent GVHD when given early after the transplant procedure. It is not known exactly for how long 
the administration of drugs is necessary before they can be discontinued without the patient developing signs 
of GVHD. Studies which have been done to date, however, indicate that the administration of cyclosporine 
during the first 5-6 months after transplantation has been beneficial. 
PROCEDURES 
Cyclosporine is given by vein twice a day, starting on the day before marrow infusion and for the first few 
weeks after transplantation when patients are usually not able to take medications by mouth. As soon as you 
are able to do so, cyclosporine will be switched to an oral preparation to be given twice a day. The dose of 
cyclosporine will be slowly reduced over a 6-month period. Dose adjustments may also be made depending 
on the side effects experienced (i.e., kidney function problems) and/or your condition. In some cases, a dose 
may not be given. 
Routine laboratory tests will be done frequently to check the response to treatment. Such testing is standard 
procedure for patients undergoing a marrow transplant. Other diagnostic tests may be carried out depending 
on your clinical condition. 
Recombinant DNA Research, Volume 15 
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