Analyzing CMV Reactivation Risks in CAR-T Cell Patients with Acute Leukemia and Lymphoma

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

This study looks at how often and why Cytomegalovirus (CMV) reactivates in patients with acute leukemia and lymphoma who are receiving CAR-T cell therapy, to see how it impacts their treatment and if they need antiviral medications.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 1 Year to 100 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Drugs / interventions: CART, CAR-T, Chimeric Antigen Receptor
• Locations: 3 sites (Paris and 2 other locations)
• Trial ID: NCT06058858 on ClinicalTrials.gov

What this trial studies

This observational cohort study investigates the incidence and risk factors associated with Cytomegalovirus (CMV) reactivation in patients undergoing CAR-T cell therapy for refractory acute leukemia and B-cell lymphoma. The study aims to understand how CMV reactivation affects clinical outcomes and the potential need for antiviral treatments. It includes both retrospective and prospective components, focusing on pediatric and adult patients who are CMV seropositive. The findings could provide insights into managing CMV-related complications in this patient population.

Who should consider this trial

Good fit: Ideal candidates include pediatric and adult patients receiving CAR-T cell treatment for refractory acute leukemia or B-cell lymphoma who are CMV seropositive.

Not a fit: Patients who are CMV seronegative or lack social security affiliation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for CMV reactivation, enhancing patient outcomes in CAR-T cell therapy.

How similar studies have performed: While there is limited data on CMV reactivation in CAR-T cell patients, previous studies have indicated that managing CMV in hematopoietic stem cell transplant recipients can lead to better outcomes, suggesting potential for success in this novel approach.

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)

Where this trial is running

Paris and 2 other locations

• Hopital Robert Debré - APHP — Paris, France (RECRUITING)
• Hopital Saint Louis - APHP - Service d'hématologie " Unité Adolescents et jeunes adultes " — Paris, France (RECRUITING)
• Hopital Saint-Louis - APHP - Service d'éhamotologie - oncologie — Paris, France (RECRUITING)

Study contacts

• Study coordinator: Jérôme Le Goff, Pr

Conditions: Cytomegalovirus Infections, Acute Leukemia, B Cell Lymphoma