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Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. Clinical research trials and Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.. Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.  Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.
Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.
For Condition: Epstein-Barr Virus Infections,Bone Marrow Transplantation
Status: Recruiting
Sponsor(s): Baylor College of Medicine , Texas Children's Hospital,The Methodist Hospital
Synopsis: In normal people, the Epstein-Barr (EB) virus infection causes a flu like illness (sometimes called infectious mononucleosis or glandular fever or kissing disease) and usually gets better when the immune system controls the infection. The virus, however, remains hidden in the body for life. After a transplant, while the new immune system is growing back, the EB virus can come out and infect cells and cause them to grow in an uncontrolled manner. Patients can develop fevers, swollen lymph nodes and damage to other organs such as kidneys and lungs. This infection acts like a cancer because the cells infected with EB virus grow very quickly and there is no known effective treatment. This sort of infection will occur in between 10-30% of patients receiving a transplant from a donor who is not a perfect match, and has been fatal in nearly all these cases. This infection occurs because the immune system cannot control the growth of the cells. We want to see if we can prevent it from happening or treat it by giving patients a kind of white blood cell called T cells that we have grown from the marrow donor. These cells have been trained to attack EB virus infected cells. The purpose of this study is to evaluate the effectiveness of using EBV specific T cells grown from a Bone Marrow Transplant (BMT) donor to attack EB virus infected cells.
Details: We will obtain blood from the donor and will first make a B cell line called a lymphoblastoid cell line or LCL by infecting the 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 your normal cells and freeze them. The marrow donor's T cells will be thawed and injected into the patients intravenous line over a period of 10 minutes. We would give one dose of the cells on or after day 45 following transplant. If the patients EBV DNA levels remain high or they have persistent disease they may be eligible to receive up to 5 additional injections of T cells at the original dose at monthly intervals. After the patient has received the T cells, they will be contacted by the research nurse or another member of the study team weekly for 6 weeks, then once every three months for a year so that we can check on progress. To learn more about the way the T cells are working, an extra 40 mls (about 8 teaspoonfuls) of blood will be taken every two weeks for six weeks after the T cell infusions, and then every three months for one year.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - All patients receiving a T cell depleted BMT from a mismatched family member or unrelated donor will be eligible for this protocol. In addition patients receiving a matched sibling transplant or T replete transplant may be eligible if they are at high risk of developing EBV LPD because of their underlying disease (e.g Wiskott-Aldrich or Ataxia Telangiectasia) or have a past history of EBVLPD or other EBV associated malignancy. Exclusion Criteria: - Exclusion criteria for BMT will be as detailed in the relevant protocol Exclusion criteria at time of administration CTLs. - GVHD of Grade II or greater. - Patients with severe renal disease (i.e., creatinine clearance less than half normal for age). - Patients with severe hepatic disease (bilirubin greater than twice normal, or SGOT greater than 3 x normal). - Patients with a severe intercurrent infection. - Life expectancy <6 weeks
Total Enrollment: 20
Location and Contact Information:
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Helen Heslop 832-824-4662
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Helen Heslop 832-824-4662
Additional Information:
Study ID Numbers: H6676; ETNA
Study Start Date: May 1993
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058812
Other Bone Marrow Transplantation Studies:
1. Relationship Between Personality and Coping Styles in Bone Marrow Transplant Candidates
2. Comparison of Quality of Life in Patients Undergoing More Intensive versus Less Intensive Chemotherapy and Radiation Preceding a Bone Marrow Transplant
3. Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.
4. National Marrow Donor Program (NMDP)
5. Sibling Donor Cord Blood Banking and Transplantation
Related Studies:
Other Bone Marrow Transplantation Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.
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