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

NCT ID: NCT06058858

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2025-04-17

Brief Summary

Letermovir is approved for the primary prevention of Cytomegalovirus (CMV) reactivation and infection in hematopoietic stem cell transplant recipients. Letermovir may be beneficial in other clinical presentation where CMV reactivates and may alter clinical outcomes. Recently Chimeric Antigen Receptor (CAR) T cells have been used for the treatment of refractory acute leukemia and B cell lymphoma. Reactivation of chronic viral infections, in particular those belonging to the Herpesviridae family can therefore be observed following CAR-T cells treatment.According to first reports, Cytomegalovirus seems to be the main virus detected. Uncontrolled CMV reactivation leads to CMV disease requiring the use of antiviral drugs associated with either hematological toxicity (ganciclovir) or renal toxicity (foscarnet) and is usually associated with poor outcomes. In addition, CMV interplays with the immune system and decreases the immunosurveillance of tumor cells and facilitates the growth or reactivation of other opportunistic infections. Therefore, CMV reactivation could also impact the outcome of CART cells treatment by increasing the existing risk of opportunistic infections in CART cells recipients and thus by increasing morbidity, length stay or require intensive care. Imbalance of the immune system usually correlates with reactivation of persistent virus like Torquetenovirus (TTV), redondovirus or pegivirus found more frequently in Hematopoietic stem-cell transplantation (HSCT) patients or patients requiring intensive care. Whether reactivations of those persistent viruses are associated or precede CMV reactivation deserve careful investigation to identify as early as possible patients at high risk and who could benefit from antiviral preventive treatment.

The objective of this trial is to determine the incidence of CMV reactivation within 3 months after infusion of CAR-T cells in CMV seropositive patients with refractory acute leukemia or B-cell lymphoma.

Conditions

Cytomegalovirus Infections; Acute Leukemia; B Cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• 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

• 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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Robert Debré - APHP

Paris, , France

Site Status: RECRUITING

Hopital Saint Louis - APHP - Service d'hématologie " Unité Adolescents et jeunes adultes "

Paris, , France

Site Status: RECRUITING

Hopital Saint-Louis - APHP - Service d'éhamotologie - oncologie

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jérôme Le Goff, Pr

Role: CONTACT

jerome.legoff@aphp.fr

+33142499493

Jérôme Lambert, Pr

Role: CONTACT

jerome.lambert@u-paris.fr

+33142499742

Facility Contacts

Marie-Emilie Dourthe, MD

Role: primary

Florence Rabian, MD

Role: primary

Roberta Di Blasi, MD

Role: primary

Other Identifiers

APH211589

Identifier Type: -

Identifier Source: org_study_id