|
LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma Clinical research trials and LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma. LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma clinical trial. Subjects often receive the most expert healthcare possible for their LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "L" Clinical Trials Conditions > LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma  LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma
LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma
For Condition: Lymphoma
Status: Recruiting
Sponsor(s): Baylor College of Medicine , The Methodist Hospital,Texas Children's Hospital
Synopsis: The purpose of this study is to find the largest safe dose of LMP2 specific cytotoxic T cells given after antibody injections, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma.
Details: We will first test a biopsy of the patient's tumor that has already been done to see if tumor cells are EBV positive. If the patient is eligible, we will then take 60-70 ml (12-14 teaspoonfuls) of blood. We will use this blood to grow T cells. We will first grow a special type of cell called dendritic cells which will stimulate the T cells and we will put a specially produced human virus (adenovirus) that carries the LMP-2a gene into the dendritic cells. These dendritic cells will then be treated with radiation so they cannot grow. They will then be used to stimulate T cells. This stimulation will train the T cells to kill cells with LMP-2a on their surface. We will then grow these LMP-2a specific CTLs by more stimulation with EBV infected cells (which we will make from the patients blood by infecting them with EBV in the laboratory). We will also put the adenovirus that carries the LMP2 gene into these EBV infected cells so that we increase the amount of LMP2 which these cells have. Again, these EBV infected cells will be treated with radiation so they cannot grow. Once we have made sufficient numbers of T cells we will test them to make sure they kill cells with LMP2a on their surface. If the patient's counts are low we may need to obtain additional blood samples to make these cells. We will also take extra blood to freeze in case the patient's immune system is slow to recover after the antibody infusions.
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: - Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin lymphoma, regardless of the histological subtype or EBV-associated T/NK cell Lymphoproliferative disease. This includes patients in second or subsequent relapse (or with active disease or in first relapse if immunosuppressive chemotherapy contraindicated). - Life expectancy of more than 6 weeks. - No severe intercurrent infection - Patient, parent/guardian able to give informed consent - HIV negative - Bilirubin less than or equal to 3x normal - AST less than or equal to 5x normal, - Hgb higher than 8.0 g/L - Creatinine less than or equal to 2x normal for age - Patients should have been off other investigational therapy including T cells therapies for one month prior to entry in this study. - Karnofsky score of over or equal to 50. - Female patients with reproductive capacity must have a negative pregnancy test. Exclusion Criteria: - Patient, parent/guardian unable or unwilling to give informed consent - HIV positive - Pregnant women - Patients with a Karnofsky score of < 50 - Patients with a severe intercurrent infection - Patients with a life expectancy of <6 weeks - Patients with a bilirubin of more than 3x normal. AST of more than 5x normal - Patients with a creatinine of more than 2x normal for age - Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
MalcolmBrenner, Study Chair, Baylor College of Medicine
Texas Children's Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Catherine Bollard 832-824-4781
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Catherine Bollard 832-824-4781
Additional Information:
Study ID Numbers: 14424; ACDAL
Study Start Date: October 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082225
Other Lymphoma Studies:
1. Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
2. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
3. Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome
4. Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
5. Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas
Related Studies:
Other Lymphoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma
|
|
|
|
|
|
|
|
