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| Sponsor: | Baylor College of Medicine |
|---|---|
| Collaborators: |
Texas Children's Hospital The Methodist Hospital System Center for Cell and Gene Therapy, Baylor College of Medicine |
| Information provided by: | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00383097 |
Purpose
The purpose of this study is to obtain blood (up to 60 ml or 12-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-specific cytotoxic T-lymphocytes (LMP1- and LMP2-CTLs) and grow them in the laboratory in such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory.
If we are successful in growing these cells and if we feel they would be helpful to the donor, we would then give the cells back to the donor.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkins Lymphoma Non-Hodgkin Lymphoma |
Genetic: LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES Genetic: LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Administration Of Lmp1- And Lmp2-Specific Cytotoxic T-Lymphocytes Following Cd45 Antibody To Patients With Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 24 |
| Study Start Date: | September 2006 |
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of EBV-positive Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL; all histological subtypes except Burkitt's lymphoma), or EBV (associated)-T/NK-LPD, or chronic active EBV infection (CAEBV) after second or subsequent relapse including after autologous or syngeneic stem cell transplant (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated). CAEBV is defined as i) illness for greater than 3 months duration (EBV-related illness or symptoms including fever, persistent hepatitis, extensive lymphadenopathy, or hepatosplenomegaly); ii) increased amounts of EBV-DNA in peripheral blood (equal or greater than 400 genome copies per ug of DNA) or abnormal high levels of EBV antibodies (VCA IgG equal or greater than 1:5120 or EA IgG equal or greater than 1:640; and iii) no evidence of previous immunological abnormalities or other recent infection that might explain the observed condition.
Patients with life expectancy greater than 6 weeks.
Patients with a Karnofsky score (age ≥16) of greater than 50 or Lansky score (age<16) of greater than 50
No severe intercurrent infection.
HIV negative donor (if autologous donor, patient must be HIV negative)
Patient, parent/guardian able to give informed consent.
Patients with bilirubin less than3 x normal, AST less than 5 x normal, and Hgb greater than 8.0
Patients with a creatinine less than 2 x normal for age
Patients should have been off other investigational therapy including T cell therapies for one month prior to entry in this study.
Female patients with reproductive capacity must have a negative pregnancy test. Women of childbearing potential must not be pregnant and must be on effective birth control. The male partner should use a condom.
Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator¡¦s discretion after approval by the CAGT Protocol Review Committee and the FDA reviewer.
Exclusion Criteria:
Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.
Contacts and Locations| Contact: STEPHEN M GOTTSCHALK, M.D. | 832-824-4179 | smg@bcm.tmc.edu |
| Contact: MALCOLM K BRENNER | 832-824-4663 | mbrenner@bcm.tmc.edu |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Texas Children's Cancer Center GCRC | Recruiting |
| Houston, Texas, United States, 77030 | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Sub-Investigator: George Carrum, MD | |
| Principal Investigator: Stephen M Gottschalk, MD | |
| Sub-Investigator: Bambi J Grilley | |
| Sub-Investigator: Robert A Krance, MD | |
| Sub-Investigator: Malcolm K Brenner, MD | |
| Sub-Investigator: Helen E Heslop, MD | |
| Sub-Investigator: Cliona M Rooney, MD | |
| Sub-Investigator: Adrian P Gee, MD | |
| Sub-Investigator: Catherine M Bollard, MD | |
| Sub-Investigator: Noelle U Gaskill | |
| Sub-Investigator: Serpil Uludag | |
| Sub-Investigator: Rammurti T Kamble, MD | |
| Sub-Investigator: Hao Liu | |
| Sub-Investigator: Andrea M Sheehan | |
| Study Director: | MALCOLM K BRENNER, MD | Center for Cell and Gene Therapy, Baylor College of Medicine |
More Information
| Responsible Party: | Helen Heslop, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00383097 History of Changes |
| Obsolete Identifiers: | NCT00608478 |
| Other Study ID Numbers: | 19275, ALDI |
| Study First Received: | September 28, 2006 |
| Last Updated: | December 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
CTLs LMP1 LMP2 CYTOTOXIC T-LYMPHOCYTES |
CD45 ANTIBODY EBV-POSITIVE HODGKIN'S NON-HODGKIN'S LYMPHOMA |
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |