RecruitingNCT06058858

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

250 participants

Start Date

Apr 17, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking the rate of a viral infection called CMV (cytomegalovirus) reactivation in patients who have received CAR-T cell therapy for leukemia or lymphoma. CAR-T therapy uses engineered versions of your own immune cells to fight cancer, but can sometimes allow dormant viruses to become active again. **You may be eligible if...** - You are a child (1-18 years old) or an adult receiving CAR-T cell treatment for leukemia or B-cell lymphoma that has returned or is not responding to standard treatment - You have tested positive for CMV antibodies in the past (meaning you have been previously exposed to CMV) **You may NOT be eligible if...** - You have never been exposed to CMV (CMV seronegative) - You or your parents (for minors) do not consent to participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Hopital Robert Debré - APHP

Paris, France

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

Paris, France

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

Paris, France

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NCT06058858


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