Autologous EBV Specific CTLs for Prophylaxis and Therapy of EBV Lymphoma Post Solid Organ Transplant
Participation in this study will be for one year. Patients will receive this treatment
either while in hospital or in the outpatient clinic. Each patient will be entered into one
of three different dosing schedules being evaluated. Three to six patients will be evaluated
on each dosing schedule. Escalation will continue until unacceptable side effects are seen.
First, patients will be given Tylenol (for any aches/pains) and Benadryl (for any minor
allergic reactions such as itching/rash). This is called premedication. Next, the T cells
will be injected into the patients' vein (intravenously) over approximately 10 minutes.
Patients will be closely watched during this time to make sure they do not experience any
bad effects such as an allergic reaction. If the patient does not respond to the T cells or
if during follow-up examinations evidence of relapse is shown, the patient may receive
another (higher) dose of T cells approximately six weeks after their first injection.
Patients may decide NOT to continue to receive this therapy (receive further injections),
however, the follow-up period will still be for one year.
Each patient will be seen every two weeks in the clinic or contacted every two weeks by the
research nurse or other member of the research team, for six weeks after the injection(s).
They will then be seen or contacted monthly for 3 months and then once every three months
for one year and again if relapse occurs or is suspected.
To learn more about the way the T cells are working and how long they last in the body, 40
mls (8 teaspoonfuls) of blood will be taken once before the injection of T-cells, every two
weeks for 6 weeks after the injection, monthly for 3 months and then every 3 months for 1
year. This amount of blood will be less for small patients. We will also take another blood
sample from the patient if relapse is suspected. Each patient will need to have a physical
examination by their physician to check on their progress.
Additionally, before the injection of T-cells, once every two weeks after the injection for
6 weeks and once every month for 3 months and then once every 3 months for one year and
again if relapse occurs or is suspected we will obtain a blood sample from the patient to
evaluate for transplant rejection. The amount of blood that we will take will be 3-5 mls
(1/2 to 1 teaspoon). If the patient has received a heart transplant they will also be asked
to have other tests such as an ultrasound or tomography (similar to an x-ray) done to help
with this evaluation.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Generate autologous, EBV-specific, cytotoxic T cell lines (CTLs) from individuals receiving or having received a solid organ transplant (SOT).
Helen Heslop, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|