MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER: 
CONTINUATION: page of 
page: 
genetic material (chromosomes). Once in the chromosomes, the neo^ gene will survive as long 
as the cell survives. The neo^ gene serves no function in the blood cells, but rather “marks” 
them so we can identify them. The blood cells, vector and three growth factors are put together 
in a mixture called a culture for 3 days. After this, the cells are removed from the culture and 
“washed” to remove any extra virus or growth factor attached to them. The “marked” cells are 
then frozen and are returned to you at the time of transplantation along with the bone marrow* 
and blood cells that have not been exposed to the vector. You will receive enough of your 
normal, unchanged bone marrow cells to produce blood count recovery in the expected time 
period after high dose chemotherapy. 
The standard blood drawings and tests that are required following bone marrow 
transplantation will be performed. These have all been explained to you in a separate consent 
document. During your hospitalization and after you are discharged, blood samples will be 
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drawn to study your blood counts and to determine whether the neo^ gene is present in the blood 
cells. Approximately two extra teaspoons of blood will be drawn three times a week for these 
research studies. Bone marrow aspirations will be obtained at 2, 4, and 6 weeks after your bone 
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marrow is given back to you to test for the presence of the neop" gene. You will be given local 
anesthesia for these bone marrow aspiration. The side effects of the biopsies include pain, 
bleeding and infection. These bone marrow aspirations are scheduled as part of the 
transplantation protocol to keep track ofyour bone marrow recovery. No extra bone marrow 
aspirations will be done because of the gene marking protocol while you are hospitalized, but an 
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extra one teaspoon of marrow will be taken during the exam to test for the neo^ . You will 
return monthly to NCI for evaluation after you are discharged from the hospital. Four extra 
teaspoons of blood will be drawn from you each month and a bone marrow aspiration will be 
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obtained every three months to determine whether your bone marrow cells contain the neo — 
gene. After this, you will return to NCI every two months at which time 4 teaspoons of blood 
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and a bone marrow biopsy will be obtained if your bone marrow cells contain the neo^ gene. 
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No further bone marrow biopsies will be obtained if the neo^ gene cannot be found on two 
successive bone marrow biopsies after you are discharged. We request that you return 
periodically to the NCI for the rest of your life so that we may follow you for any side effects 
that may occur. Should you die, for any cause, we will request that an autopsy be performed to 
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study whether the neop- gene is present in your body. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-251 4-1 (10-84) 
NIH-2514-2 (10-84) P.A.: 
09-25-0099 
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Recombinant DNA Research, Volume 16 
