MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 25 M- 1 , Consent to Participate in A Clinical Research Study 
NIH 25 1 4-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER: 
CONTINUATION: page A of _JL_ page: 
Should you die, for any cause, we will request that an autopsy be performed to study whether the 
neo^ gene is present in your body. 
If your leukemia relapses or is found in a new part of your body after bone marrow 
transplant, a bone marrow aspiration and biopsy will be obtained under local anesthesia to look 
for the presence of the neo^ gene in the tumor cells as well as to assess the extent of your 
disease. 
RISKS AND TOXICITIES 
No side effects from the necA ^ marker genes and the transporter viruses to be used in this 
study have been seen in animal studies or in the very limited human studies on gene transfer 
which began in May, 1989. However, since this is a very new procedure, the risks may not be 
known. There are some theoretical risks to this procedure. First, even though the viruses used to 
insert the gene into your bone marrow and blood cells cannot grow and are considered harmless, 
it is possible that events could occur within the cells that allow the viruses to grow or cause the 
cell to become cancerous. It is also theoretically possible that you could become infected with 
the virus. Since this has never happened, the consequences of such an infection are unknown. 
Also, the inserted gene produces a substance that inactivates the antibiotics neomycin and 
amikacin. These antibiotics are rarely routinely used during bone marrow transplantation or 
other medical care. The antibiotics routinely used are not inactivated, and these will be given to 
you to treat any bacterial infections that might occur. 
It is possible that leukemia cells that may be present in your bone marrow or blood stream 
D 
may also be infected with the neo^- gene. We will study this if your leukemia relapses. We do 
D 
not believe you would be harmed should a leukemic cell receive this neo^ gene: however, little 
information exists about this. It is possible that the neo^ gene could alter the leukemia cell 
D 
making it more or less malignant It is also possible that the growth factors used to put the neo— 
gene into the bone marrow and blood cells could cause leukemic cells to grow. We believe that 
these possibilities are unlikely to cause you any harm if they did happen, but we can’t be sure. 
There is also a small possibility that you could have an allergic reaction to the “marked” cells 
with the neo^- gene due to residual antibody that could be attached from the immunoadsorption 
column or residual growth factors that could be attached from the culture. We think it is unlikely 
that any small amount of antibody or growth factor attached to the cells would cause you any 
harm, including an allergic reaction, but it is theoretically possible. Should an allergic reaction 
occur, the physician present while you are receiving the cells will treat you for the reaction. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (10-84) 
NIH-251 4-2 (10-84) P.A.: 09-25-0099 
Recombinant DNA Research, Volume 16 
[ 197 ] 
