A new study assessing the potential role of the gut microbiome in patients with diffuse large B-cell lymphoma (DLBCL) treated with chimeric antigen receptor (CAR)-T cell therapy is now open.
The observational prospective cohort study will enroll an estimated 90 participants who were 18 years of age and over with DLBCL undergoing CAR-T cell therapy over 3 years at the Institute of Hematology in Bologna, Italy. Fecal samples will be collected until 18 months after CAR-T cell treatment.
Read more about DLBCL experimental therapies
Patients with a second malignancy or other concomitant diseases that could affect compliance or the interpretation of the results are not eligible to take part in the study.
The primary outcome measure will be the characterization of the compositional and functional modifications of the gut microbiome. The secondary outcome measure will be the possible correlation between the gut microbiome and the outcomes of CAR-T cell therapy in terms of response, toxicity, and disease control.
The study, which is sponsored by the University of Bologna, is not yet recruiting participants. It is estimated to start in April 2023 and be completed in December 2027.
DLBCL is a type of non-Hodgkin lymphoma in which B lymphocytes become abnormal and infiltrate tissues and organs in a diffuse manner.
CAR-T cell therapy is a therapy in which T cells are altered so that they can recognize and destroy cancerous cells. The approach has led to significant clinical outcomes in some patients with DLBCL. However, there is still a significant difference in patient responses to the treatment.
Research has shown that the gut microbiome may play an important role in prognosis and response to treatment in different types of cancer. However, its potential role in the response of lymphomas to CAR-T cell therapy is currently unknown.
Role of the gut microbiome in the outcome of diffuse large B-cell lymphoma patients treated with CAR-T cell therapy (MicroCar). ClinicalTrials.gov. February 13, 2023. Accessed February 23, 2023.