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Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts. Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult 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 website dedicated 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 a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like 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 volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes 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. Human subjects often obtain the finest 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, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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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 Epstein-Barr Virus Infections Studies:
1. Genetic Studies of Chronic Active Epstein-Barr Disease
2. Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs).
3. Protein Studies of the Epstein-Barr virus in Ethnically Diverse Populations
4. Giving Epstein-Barr Virus (EBV) Specific Killer T Lymphocytes to Patients who have had Donor Marrow Grafts.
5. Treating Severe Chronic Epstein-Barr Virus (EBV) Infection with EBV Specific Cytotoxic T Lymphocytes (CTLs)
Related Studies:
Other Epstein-Barr Virus Infections 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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