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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how often a virus called Cytomegalovirus (CMV) reactivates in patients who receive a special type of treatment known as CAR-T cell therapy for acute leukemia or B-cell lymphoma. The researchers want to find out if patients who have had CMV in the past (CMV seropositive) are at risk of reactivating this virus within three months after receiving CAR-T cells. This is important because uncontrolled CMV can lead to serious health problems and affect the success of the cancer treatment.

To participate in this study, patients must be between 1 and 18 years old (children) or adults receiving CAR-T cell therapy for their cancer and have a history of CMV infection. Participants will be closely monitored for signs of CMV reactivation after their treatment. The goal is to understand how CMV affects recovery and to identify patients who might benefit from preventive antiviral medications. This research could help improve care for patients undergoing CAR-T cell therapy.

Gender

ALL

Eligibility criteria

• Common inclusion criteria :
• • Paediatric (1 to 18 years old) receiving CART-T cells treatment for refractory acute leukemia or B-cell lymphoma
• • Adult receiving CART-T cells treatment for refractory acute leukemia or B-cell lymphoma
• • CMV seropositive patients
• • Inclusion criteria : retrospective part
• • Provide written non-opposition from the patient signed by investigator
• • If the patient is a minor, provide written non-opposition from both parents and child (if age appropriate to collect their non-objection) or child and the legal representative in case only one parent is alive, signed by investigator
• • Inclusion criteria : prospective part
• • Provide written consent form signed by patient and investigator
• • If the patient is a minor, provide written consent form signed by investigator and both parents or signed by investigator and the legal representative in case only one parent is alive
• Exclusion Criteria:
• • CMV seronegative patients
• • Lack of affiliation to a social security scheme (as a beneficiary or assignee)
• • Patients under guardianship / curatorship
• • Patient under AME (state medical aid)