Incidence and Risk Factors of CMV Reactivation in Patients Receiving CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis

What this Trial Is About

Researchers are studying the occurrence and risk factors of Cytomegalovirus (CMV) reactivation in patients with refractory acute leukemia or B-cell lymphoma who receive Chimeric Antigen Receptor (CAR) T-cell therapy. CMV reactivation is common after CAR-T treatment and can lead to serious complications, including increased infections and worse health outcomes. The study aims to understand CMV reactivation within three months post-CAR-T cell infusion in patients who are CMV seropositive. This observational study involves monitoring patients who have received CAR-T cell therapy for their blood cancers. It focuses on CMV reactivation and other related viruses such as anellovirus, pegivirus, and redondovirus. The study tracks these viral infections and their impact on patient health, including their correlation with bacterial or fungal infections and the expansion of CAR-T cells. Both retrospective and prospective parts involve collecting data and patient consent. Participants will be followed for up to three months after inclusion, during which their health, viral reactivation rates, immune response, quality of life, and costs related to CMV disease will be assessed. The primary measure is the rate of CMV reactivation within this period. Secondary measures include rates of other viral infections, mutation detection in viral genes, and overall health outcomes. The study is sponsored by Assistance Publique - Hôpitaux de Paris and involves regular monitoring and data collection to better understand these infections in CAR-T cell recipients.

Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis