I 
I 
INJECTION OF CELLS 
The cells will then 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/your child 
| agreed and were well enough. 
BLOOD TESTS AFTER THE TRANSPLANT 
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. 
CONFIDENTIALITY 
Your/your child's case will be treated in complete confidence, unless you specifically agree 
otherwise. However, approved people from the Food and Drug Administration and 
National Institutes of Health, as well as St. Jude clinical staff, may review the charts. 
RISKS AND SIDE EFFECTS 
These types of T 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 (graft) recognizes that your/your child's body tissues 
(host) are different from those of the donor. When this happens cells in the graft may attack 
the host's skin, liver and intestines. 
If you/your child has GVHD after the transplant you will not be able to get the T Cells. If 
you/your child gets GVHD after the T cells have been given we will not give you any more 
of them. We will treat you/your child with steroids, and if necessary, an antibody to kill the 
T cells. There may also be a risk from exposure to donor EB virus but this will be less than 
with the infusion of the donor's bone marrow. 
No bad effects at all have been seen in animal studies using the gene markers or in more 
than 30 people treated with marker genes. Still there may be some risks. It is possible the 
;j mouse virus may be able to recover in the cell; it may even be able to cause cancer. We 
| think this is very unlikely but cannot rule it out yet. 
I| 
| BENEFITS 
We hope that these cells will reduce the risk of you/your child developing a serious or fatal 
infection with EB virus and that the marker genes will allow us to see how the cells are 
working. 
I ALTERNATIVE TREATMENT 
i You/your child may have the transplant without receiving the cytotoxic T lymphocytes. 
I 
i 
Recombinant DNA Research. Volume 17 
[219] 
