This study is investigating the effectiveness of T-cell immunotherapy in diffuse large B-cell lymphoma (DLBCL) patients with tumors that are EBV+ (positive for Epstein-Barr virus). This study is recruiting in Duart, California, Washington, D.C., Baltimore, New York, Pittsburgh, and Houston.
The details
It is thought that individuals who have experienced infection with the Epstein-Barr virus (EBV) may have a higher risk of developing certain lymphomas. Adoptive T-cell therapy is showing promise for lymphoma patients with EBV+ tumors. This type of treatment involves the transfer of T cells to the patient to target virus-associated cancer tumors.
This study is investigating the best overall response of lymphoma patients with EBV+ tumors to T-cell immunotherapy. Patient response is evaluated using rates of complete response (complete disappearance of tumors), response duration (time from treatment response to disease progression), and disease control (response to treatment or no disease progression). Effectiveness is evaluated using rates of overall (time from treatment until death from any cause), progression-free (time from treatment before disease progression or death), and disease-free (time after treatment without signs of cancer) survival. Safety is evaluated from the number of patients experiencing side effects.
Who are they looking for?
To participate in this study, patients must have EBV+ DLBCL who relapsed after autologous stem cell transplantation, or who were not eligible for that treatment. Absolute lymphocyte levels must be more than 500/microliter. CT scans or other imaging taken within 3 months must show active lymphoma.
Patients who have refractory (not responding to treatment) DLBCL or bulky disease cannot participate in this study. Patients who previously received allogeneic hematopoietic stem cell transplantation (alloHSCT) cannot participate. Patients who are positive for HIV, hepatitis B, hepatitis C, syphilis, or human T cell leukemia virus cannot participate. Patients with uncontrolled infections or poor immunity cannot participate.
How will it work
Patients receive up to 5 doses of T cells by IV every two weeks. These T cells are autologous, meaning that they originate from the patient. The cells are EBV-specific, so they only target cancer cells infected with EBV.
Patients are followed up at 12 months to determine the best overall response after treatment. Patient response to treatment is also measured with rates of complete response, response duration, and disease control.
