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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 2, 2008 | ||||||||
| Last Updated Date | June 9, 2009 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Estimated Primary Completion Date | May 2015 (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 NCT00671164 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | T-Lymphocytes in Treating Patients With Epstein-Barr Virus-Positive Lymphoma, Lymphoepithelioma, or Severe Chronic Epstein-Barr Virus Infection Syndrome | ||||||||
| Official Title ICMJE | Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma | ||||||||
| Brief Summary | RATIONALE: Treating a person's or donor's T-lymphocytes in the laboratory and reinfusing them may cause a stronger immune response to kill Epstein-Barr virus-associated cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of T-lymphocytes in treating patients with Epstein-Barr virus-positive lymphoma, lymphoepithelioma, or severe chronic Epstein-Barr virus infection syndrome. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according disease status (relapsed lymphoma/lymphoepithelioma or at high risk for relapse vs in remission or has minimal residual disease after autologous or syngeneic stem cell transplantation vs in remission or has detectable disease after allogeneic stem cell transplantation). Peripheral blood mononuclear cells (PBMC) are collected from the patient or a donor for generation of LMP-specific cytotoxic T-lymphocytes (CTL). PBMC are stimulated with antigen-presenting cells (APC) expressing LMP1/2 antigen and expanded with aldesleukin. Patients receive autologous or allogeneic LMP-specific CTLs IV over 1-10 minutes on days 0 and 14. Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of CTLs once a month. After completion of study treatment, patients are followed at 3, 6, 9, and 12 months and then annually for 5 years. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | Bollard CM, Gottschalk S, Leen AM, Weiss H, Straathof KC, Carrum G, Khalil M, Wu MF, Huls MH, Chang CC, Gresik MV, Gee AP, Brenner MK, Rooney CM, Heslop HE. Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood. 2007 Oct 15;110(8):2838-45. Epub 2007 Jul 3. | ||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 36 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | |||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00671164 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000595213, BCM-H-9936-ALCI | ||||||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | June 2009 | ||||||||
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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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