Status:
RECRUITING
Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cytomegalovirus Infections
Acute Leukemia
Eligibility:
All Genders
1-100 years
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 p...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 17 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06058858
Start Date
April 17 2024
End Date
April 17 2025
Last Update
July 17 2024
Active Locations (3)
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1
Hopital Robert Debré - APHP
Paris, France
2
Hopital Saint Louis - APHP - Service d'hématologie " Unité Adolescents et jeunes adultes "
Paris, France
3
Hopital Saint-Louis - APHP - Service d'éhamotologie - oncologie
Paris, France