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Sponsors and Collaborators: |
Baylor College of Medicine The Methodist Hospital System Texas Children's Hospital Center for Cell and Gene Therapy |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00058773 |
A lot of patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of 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. We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells and give them back to the patient.
The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T lymphocytes, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma.
Condition | Intervention | Phase |
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Hodgkin Disease Non-Hodgkins Lymphoma |
Procedure: Infusion of EBV Specific Cytotoxic T-Lymphocytes |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Administration of Autologous Neomycin Resistant Gene Marked EBV Specific Cytotoxic T-Lymphocytes as Therapy for Patients Receiving Autologous Bone Marrow Transplant for Relapsed EBV-Positive Lymphoma. |
Estimated Enrollment: | 18 |
Study Start Date: | January 1996 |
We will take 60-70 ml (12 teaspoonfuls) of blood from the patient. We will first make a B cell line called a lymphoblastoid cell line or LCL by infecting this blood with a laboratory strain of EBV called B95. We 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. We will then test the T cells to make sure that they kill the EBV infected cells and not the normal cells and freeze them.
The cells will be thawed and injected into the patients vein (IV) over 10 minutes, after pretreatment with Tylenol and Benadryl. A total of two doses will be given two weeks apart. All of the treatments will be given at Texas Children's Hospital or The Methodist Hospital.
We will follow the patient 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 20-40 mls (4-8 teaspoonfuls) of blood will be taken before each infusion and then 24 hours after each infusion, 3-4 days after each infusion and then weekly for 2 weeks after each infusion (total of 9 times). After this, blood will be taken every 3 months for 1 year.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
Exclusion Criteria:
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 |
Study ID Numbers: | H6422, Angela |
Study First Received: | April 11, 2003 |
Last Updated: | April 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00058773 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Lymphatic Diseases Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse |
Neomycin Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |