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| Tracking Information | |||||
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| First Received Date ICMJE | May 3, 2004 | ||||
| Last Updated Date | December 20, 2007 | ||||
| Start Date ICMJE | October 2003 | ||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00082225 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody for Lymphoma | ||||
| Official Title ICMJE | Administration of LMP2a-Specific Cytotoxic T-Lymphocytes Following CD45 Antibody to Patients With Relapsed EBV-Positive Hodgkin's or Non-Hodgkin's Lymphoma | ||||
| Brief Summary |
Although we have seen some clinical benefit in our initial Hodgkin's study the CTL have not expanded as well in these patients as in patients post T cell depleted BMT, where EBV-specific CTL expanded by up at least four logs after infusion and persisted for up to 86 months. We propose that failure to expand effectively in Hodgkin's patients in part reflects a T helper 2 environment due to the T cell infiltrate at sites of disease. In this inhibitory environment, ex vivo-expanded CTL may be required to circumvent in vivo inhibition and may fail to expand or be diverted along the T helper 2 pathway despite an initial tumor-specific response. In addition to these intratumoral Th2 inhibitory cells, we propose that homeostatic mechanisms act on adoptively transferred tumor specific CTLs to prevent their expansion and long-term function in vivo in patients with a normal T cell level. We hypothesize that the expansion, function and anti-tumor activity of infused CTL may be increased dramatically by depleting the lymphoid compartment of all T cells including negative regulatory T cells and Th2 cells by pre-treating patients. The lytic CD45 monoclonal antibody can accomplish this, and its short half-life will allow rapid infusion of therapeutic cells. |
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| Detailed Description | 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.
Dose Levels of CTLs The following dose levels will be evaluated: Each patient will receive 1 injection, according to the following dosing schedules: 2x 107 cells/m2 5 x 107 cells/m2 1 x 108 cells/m2 Patients will be pre-medicated with Benadryl 1mg/kg IV (max 50) and Tylenol 10mg/kg po (max 650). Cell Administration EBV specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 4 | ||||
| Estimated Completion Date | December 2020 | ||||
| Estimated Primary Completion Date | December 2020 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00082225 | ||||
| Responsible Party | Helen Heslop, MD, Baylor College of Medicine | ||||
| Study ID Numbers ICMJE | 14424, ACDAL | ||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Baylor College of Medicine | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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