Epstein-Barr Virus-Related Hodgkin Lymphoma Clinical Trial
Official title:
Administration of Neomycin Resistance Gene Marked EBV Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma
Patients have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma which has
come back or not gone away after treatment, including the best treatment known for relapsed
Lymphoma.
Patients are being asked to volunteer to be in a research study using Epstein Barr virus
specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been
used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been
used successfully in children with other types of blood cancer caused by EBV after bone
marrow transplantation. Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of
infection with the virus that causes infectious mononucleosis Epstein Barr virus before or
at the time of their diagnosis of the Lymphoma. EBV is often found in the cancer cells
suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are
very clever because they are able to hide from the body's immune system and escape
destruction. Investigators want to see if it's possible to grow special white blood cells,
called T cells, that have been trained to kill EBV infected cells.
Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic
T cells, to learn what the side effects are and to see whether this therapy might help
patients with Hodgkin disease and non-Hodgkin Lymphoma.
The investigators will take 60-70 ml (12 teaspoonfuls) of blood from the patient to make a B
cell line called a lymphoblastoid cell line or LCL by infecting the blood with a laboratory
strain of EBV called B95-8. The investigators will then use this EBV infected cell line
(which have been treated with radiation so that they cannot grow) as stimulator cells and
mix it with more blood. This stimulation will train the T cells to kill EBV infected cells
and result in the growth of an EBV specific T cell line. The investigators will then test
the T cells to make sure that they kill the EBV infected cells and not normal cells and
freeze them.
Patients 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
irreversible or life threatening side effects considered to be related to the T cells are
seen.
The cells will then be thawed and injected into the patients' vein over 10 minutes, after
pretreatment with Tylenol and Benadryl. Tylenol and Benadryl are given to prevent a possible
allergic reaction to the T cell administration. Initially, two doses of T cells will be
given two weeks apart. If after the second infusion there is a reduction in the size of the
patient's lymphoma on CT or MRI scan as assessed by a radiologist, the patient can receive
up to six additional doses of the T cells. All of the treatments will be given at Texas
Children's Hospital or the Methodist Hospital.
Patients will be followed in the clinic after the injections. To learn more about the way
the T cells are working and how long they last in the body, an extra 40 mls (8 teaspoonfuls)
of blood will be taken before each infusion and then 24 hours after each infusion, 3-4 days
after each infusion and at 1, 2, 4, and 6 weeks post infusion and then at 3, 6, 9 and 12
months post infusion. The blood may be drawn from the central line at the time of regular
blood tests. This blood will be used to test for the frequency and activity of EBV specific
T cells. A total of at least 122 teaspoons (approximately 40 tablespoons) of blood will be
collected during participation in this study.
If the patient decide to withdraw at any time during the study both samples and data
collected during participation will be maintained.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03546101 -
Early Detection of Epstein-Barr Virus Related Disease.
|