Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma (ALDI)
The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes 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.
This trial is for patients that have a type of lymph gland cancer called Hodgkin or non-Hodgkin lymphoma, or chronic active Epstein Barr virus (EBV) infection, which has come back or not gone away after treatment, including the best treatment we know.
This is a research study using special immune system cells called LMP1- and LMP2-specific cytotoxic T lymphocytes (LMP1- and LMP2-CTLs), a new experimental therapy. As in chronic active EBV infection, some patients with Hodgkin or non-Hodgkin lymphoma show evidence of infection with the virus that causes infectious mononucleosis (EBV) before or at the time of their diagnosis of the Lymphoma. EBV is found in the cancer cells of up to half the patients with lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in the patient's blood and affect EBV-positive cells. In this present study we are trying to find out if we can improve this treatment by growing T cells that only recognize two of the proteins expressed on lymphoma cells called LMP1 and LMP2. These special T cells are called LMP1- and LMP2-specific cytotoxic CTLs.
|Hodgkins Lymphoma Non-Hodgkin Lymphoma||Genetic: LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES Genetic: LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 or Chronic Active EBV Infection (ALDI)|
- Dose limiting Toxicity: Two patients in each cohort are followed [ Time Frame: 6 weeks post CTL infusion ]
- Safety: All patients who received CD45 MAbs and LMP1- and LMP2-CTL infusions will be included in the safety analysis of this combination regimen [ Time Frame: 1 year ]
- Laboratory data which includes CBC, BUN, creatinine, etc. will be examined at pre-infusion, and at 1, 2, 4, 6, 8 weeks post- CTL infusion, 3-month intervals for the first year [ Time Frame: 1 year ]
- Frequency of T cells specific for LMP1-, LMP2-, and other EBV-antigens as well as T cell specific for CMVpp65 will be measured and summarized at pre and post-infusion time points [ Time Frame: 1 year ]
- Changes of T cells specific for LMP1-, LMP2-, and other EBV-antigens as well as for CMVpp65 from pre-infusion to each time point of post-infusion in the overall patient group. [ Time Frame: 1 year ]
- Analysis of immunologic function of tetramer-positive cells in peripheral blood, and EBV-DNA in plasma will be performed at each time point of follow-up and paired comparisons of changes from baseline will be performed. [ Time Frame: 1 year ]
- Frequency of T cells specific for adenovirus and EBV. [ Time Frame: 1 year ]
- Analysis of anti-tumor activity; Overall response rates as well as by dose groups will be presented after the end of CTL infusion. [ Time Frame: 8 weeks ]
|Study Start Date:||September 2006|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Genetic: LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383097
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Study Director:||MALCOLM K BRENNER, MD||Center for Cell and Gene Therapy, Baylor College of Medicine|