Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes for the Prophylaxis and Treatment of EBV, CMV, and Adenovirus Infection Post Allogeneic Stem Cell Transplant (VIRAGE)
Blood has been previously taken from the patient and the donor to make the cells.
To make the special cell line, special blood cells called dendritic cells (DCs)were made
first from the donor blood. Then, a specially produced gene called a plasmid that carries
the adenovirus, CMV, and EBV genes was introduced into the dendritic cells. Dendritic cells
with these new genes are then mixed with T cells to stimulate them. This stimulation trains
the donor T cells to kill cells that are infected with CMV, EBV, and adenovirus. Once a
sufficient numbers of T cells were made, they were tested to make sure they killed the
patient's cells infected with these viruses, but not the patient's normal cells, and were
If the donor has never been infected with CMV, the CTLs made for the patient may not have
activity against a CMV infection. If these donor CTLs show no activity against CMV
infection, the cells will not be given.
The patient may receive Benadryl (diphenhydramine) and Tylenol (acetaminophen). Then, the
donor's special cells will be thawed and injected into the patient's intravenous line. After
the patient receives the cells, the levels of these three viruses in the patient's blood
will be monitored. Investigators will also take blood to see how long the T cells given to
the patient are lasting in the patient's body.
If the special cell infusion has helped the infection or if the patient has had a treatment
(for example with steroid drugs) that might have destroyed the T cells that were given to
them, then the patient is allowed to receive up to 2 more doses of the cells.
The patient will continue to be followed by his/her transplant doctors after the injection.
The patient will either be seen in the clinic or contacted by a research nurse to follow up
for this study every week for 6 weeks then at 8 weeks, and 3, 6, and 12 months. The patient
may have other visits for standard care.
The patient will also have regular blood tests done to follow counts and the viral
infection. To learn more about the way the T cells are working in the patient's body, up to
an extra 30-40 ml (6-8 teaspoons) of blood will be taken before the infusion and then at 1,
2, 4, 6, and 8 weeks and 3 months. Blood should come from the central intravenous line, and
should not require extra needle sticks. Total time participation for this study will be 1
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of dose limiting toxicity in subjects receiving rapidly-generated donor-derived multivirus-specific CTLs
Safety and toxicity outcomes including DLTs, GvHD, clinical signs of viral infections, secondary graft failure and laboratory measurements will be summarized using descriptive statistics for each dose level (frequency table, means, standard deviations, medians and ranges).
Helen E Heslop, MD
Baylor College of Medicine
United States: Institutional Review Board
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|