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

NCT06058858 | Recruiting

• 1 other identifier: APH211589
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Rate of CMV reactivation

  Rate of CMV reactivation occurring within the first 3 months after CAR-T-cell infusion in paediatric and adult patients treated for refractory B cell acute lymphoblastic leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL).

  Up to 3 months after inclusion

Secondary Outcomes (12)

• Rate of CMV disease

  Up to 3 months

• Rate of anellovirus infection

  Up to 3 months

• Rate of pegivirus infection

  Up to 3 months

• Rate of redondovirus infection

  Up to 3 months

• Correlation between CMV reactivation and the occurrence of other bacterial or fungal infections

  Up to 3 months

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric and adult patient treated by CAR-T cells

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

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

MeSH Terms

Conditions

Cytomegalovirus Infections; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jérôme Le Goff, Pr

CONTACT

+33142499493; jerome.legoff@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: April 17, 2024
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

FR (3)