THE FRED HUTCHINSON CANCER RESEARCH CENTER 
AND THE UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE 
DEPARTMENT OF MEDICINE, DIVISION OF ONCOLOGY 
Consent to Donate Blood and a Skin Biopsy for a Study of Adoptive Immunotherapy as Treatment for 
HIV Infection - Bone Marrow Donor 
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 
Laboratory Medicine/Medicine, UW. 
24-hour emergency phone: 667-5001 
BACKGROUND AND PURPOSE 
Bone marrow transplantation is potentially curative therapy for patients with malignant lymphoma. However, 
for patients who are seropositive for HIV indicating infection with this virus, the ultimate success of the 
transplant procedure will depend on successful eradication of HIV in the recipient’s body. The chemotherapy 
and radiation therapy the recipient will receive prior to the transplant will destroy the recipient’s bone marrow 
and blood cells, which are major reservoirs of HIV infection. In order to prevent the spread of HIV to the 
donor bone marrow, we are evaluating the use of the antiviral drug zidovudine (AZT) and a treatment called 
adoptive immunotherapy to boost the recipient’s immunity to HIV following the bone marrow transplant. 
The adoptive immunotherapy part of this treatment will require isolating blood cells called T lymphocytes 
which can recognize and kill HIV infected cells from the bone marrow transplant recipient approximately 
three months prior to transplant. These T lymphocytes are not infected with HIV and will kill cells that are 
infected with the virus. However, to grow these cells in culture to the numbers required to reconstitute 
immunity to HIV in the bone marrow transplant recipient, will require additional lymphocytes which are 
irradiated and used as feeder cells for the T cell cultures. You, the bone marrow donor, are the best source 
of these lymphocytes since you are HLA matched with the recipient. We will also be monitoring the 
reconstitution of immunity to HIV and other viruses following the bone marrow transplant. To do this, it is 
necessary to have other cells in the laboratory that are of the same HLA type or "matched" with those of the 
bone marrow transplant recipient. These cells can be derived from a blood sample and a skin biopsy. 
PROCEDURES 
We will begin to grow the HIV-specific T cells from the bone marrow transplant recipient beginning three 
months prior to transplant. Therefore, it is necessary to obtain a peripheral blood sample as well as a 
leukopheresis from you. In addition, to be ready to monitor recovery of immune responses following the 
transplant, we require a skin biopsy which will also be taken from you pretransplant. These procedures are 
described below. 
Blood drawing: One sample is taken pretransplant by venipuncture of your arm vein using a 
small bore (21 or 23 gauge) needle. The volume of blood required is 60 ml (4 Tbls.). 
Leukopheresis: You will be required to undergo two leukophereses. Pheresis is a standard 
medical procedure where large numbers of selected blood products can be obtained. Each 
pheresis requires insertion of a needle into both your arms and takes from one to four hours. 
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