ASSENT FORM - PATIENT AGE 7-18 YEARS FOR CTL THERAPY 
ASSENT 
You have a type of blood cell cancer that is very hard to cure with standard treatments and 
you/your child will receive a bone marrow transplant. Because you do not have a brother 
or sister whose marrow is a "perfect match", this bone marrow will come from a donor 
whose marrow is the best match available. As this marrow will not be as closely matched 
as a brother or sister who is a "perfect match" there is a higher risk of problems. One of 
these problems is that because the new immune system may be slow to grow back you will 
be at risk of serious or fatal viral infections. 
One virus that can cause problems after this type of transplant is Epstein Barr virus (EB 
virus). In normal people, this virus causes a flu like illness (sometimes called infectious 
mononucleosis) and usually gets better when the immune system controls the infection. 
However the virus remains hidden in the body. After a transplant, while the new immune 
system is growing back, the EB virus can come out and infect cells and cause them to grow 
in an uncontrolled manner. 
This infection occurs because the immune system cannot control the growth of the cells. We 
want to see if we can prevent it from happening by giving you special T cells that we have 
grown from the marrow donor. These cells have been trained to attack EB virus infected 
cells. The cells will be injected into the central line over 10 minutes with a premed. We 
would give four doses every week starting at Day 45 after the transplant if you agreed and 
were well enough. 
To learn how long these T cells last when we have given them, we will mark them with a 
special virus. This special virus is like a taxicab and drpos off a marker in your cells. 
To learn more about the way the T cells are working and how long they are lasting, an extra 
10-20 mis (about 2 tablespoons) of blood will be taken every week for six weeks after the 
T cell infusions, and then every month for one year. It should come from the central line, 
and should not require extra needle sticks. 
SIDE EFFECTS 
These types of cells have been given to animals and to some patients with no side effects. 
However there is a possibility that these T cells might try to attack other parts of your/your 
child's body and cause graft versus host disease (GVHD). GVHD occurs when cells from 
your/your child's bone marrow donor like the marrow graft or these T cells (graft) 
recognizes that the body tissues of the patient (host) are different from those of the donor. 
When this happens cells in the graft may attack the host skin, liver and the gut. 
If you/your child have GVHD after the transplant you/your child will not be able to get the 
T cells. If you/your child get GVHD after the T cells have been given we will not give 
you/your child any more of these. We will treat you/your child with steroids and if 
necessary an antibody to kill the T cells. 
T2221 
Recombinant DNA Research, Volume 17 
