LMP2a-Specific Cytotoxic T-Lymphocytes, Lymphoma (ACDAL)

Stopped early · Phase 1

Conditions studied: Lymphoma

In brief

Patients have a type of cancer called Hodgkin's lymphoma or non-Hodgkin's lymphoma, which has come back or not gone away or is at high risk for coming back after treatment, including the best treatment investigators know for this disease. Investigators are asking the patient to volunteer to be in a research study using a new experimental therapy consisting of special immune system cells called LMP2 specific cytotoxic T lymphocytes in combination with a special protein called a monoclonal antibody. Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (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. Investigators want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow and solid organ transplant called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. They grew T cells in the laboratory that recognized all 9 proteins and were able to prevent and treat post transplant lymphoma. However in Hodgkin disease and non-Hodgkin Lymphoma the tumor cells only express 2 EBV proteins. In a previous study investigators made T cells that recognized all 9 proteins and gave them to patients with Hodgkin disease. Some patients had a partial response to this therapy but no patients had a complete response. Investigators think one reason may be that many of the T cells reacted with proteins that were not on the tumor cells. They are now trying to find out if they can improve this treatment by growing T cells that only recognize one of the proteins expressed on Lymphoma cells called LMP-2. These special T cells are called LMP-2 specific cytotoxic T-lymphocytes (CTLs). In this study investigators also are trying to see if they can improve these results by treating patients first with a special protein called an antibody and then giving the EBV specific T cells. The reason for doing this is that EBV specific T cells have worked very well in bone marrow transplant patients to prevent and treat EBV cancers. These patients have very few of their own immune cells when they are given the trained T cells and therefore there is a lot of space for the trained cells to grow. Investigators hope that they can improve the effect of the trained T cells in Hodgkin disease and non-Hodgkin Lymphoma patients by first temporarily removing the patient's own T cells before giving the trained cells.

Key facts

Study ID: NCT00082225
Run by: Baylor College of Medicine
People needed: 4
Starts: 2003-10-01
Expected to finish: 2008-01-01
Last updated by the study team: 2017-02-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 including post autologous or syngeneic stem cell transplant (or with active disease or in first relapse if immunosuppressive chemotherapy contraindicated or if the patient has relapsed multiple times and is currently in remission but has a high risk of relapse). (group A) OR Patients who have relapsed after allogeneic stem cell transplant for Hodgkin's Lymphoma or non-Hodgkin's Lymphoma (Group B)
Life expectancy of greater than or equal to 6 weeks
No severe intercurrent infection
Patient, parent/guardian able to give informed consent
Donor must be HIV negative (if autologous product used - patient must be 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
No evidence of GVHD >Grade II at time of enrollment
Female patients with reproductive capacity must have a negative pregnancy test

You may not qualify if…

Patient, parent/guardian unable or unwilling to give informed consent
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
GVHD greater than Grade II at time of enrollment
Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. 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 CCGT Protocol Review Committee and the FDA reviewer.

Where it is running

Texas Children's Hospital — Houston, Texas, United States
The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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