Specific Immune Reconstitution After Allogeneic Transplantation and Letermovir Prophylaxis
Key facts
- Who runs it
- University Hospital, Limoges
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 50 people enrolled
- Started
- 6 Sept 2022
- Ended
- 13 Oct 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Letermovir
- Comparator
- Record updated
- 9 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- CMV-seropositive patient included in the NAViRe cohort
- Patient having signed a specific consent for the CIRCLE study
Who cannot take part
- Patient not included or not includible in the NAViRe cohort
- Patient included in the NAViRe cohort but who refused the Circle protocol
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Cytomegalovirus (CMV) is a major cause of morbidity in hematopoietic stem cell transplant recipients, with both direct effects, including CMV disease, and indirect effects, such as graft-versus-host disease (GVHD) and increased immunosuppression.
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Virological monitoring and preemptive treatment with ganciclovir have reduced the incidence of CMV disease from approximately 30% to 2-6%, but have not eliminated the indirect morbidity associated with viral replication. Letermovir, a non-hematotoxic antiviral agent targeting the CMV terminase complex, has demonstrated efficacy in preventing CMV infection in this population.
The CIRCLE study aims to describe the evolution of global and CMV-specific immune reconstitution in CMV-seropositive hematopoietic stem cell transplant recipients receiving or not receiving letermovir prophylaxis, and to characterize the immune response over time.
The 2 groups in the trial
- Patients receiving letermovir prophylaxisTreatment being tested
CMV-seropositive hematopoietic stem cell transplant recipients receiving letermovir as primary prophylaxis and included in the NAViRe cohort. The study will describe overall and CMV-specific immune reconstitution, including its evolution during follow-up, using immunological and virological assessments.
Treatment: Letermovir
- Patients not receiving letermovir prophylaxisOther group
Observational Cohort. CMV-seropositive hematopoietic stem cell transplant recipients included in the Cryostem cohort who did not receive letermovir as primary prophylaxis. The study will describe overall and CMV-specific immune reconstitution, including assessments before transplantation and at day 100 after transplantation.
Treatment: Comparator
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Specific Immune Reconstitution After Allogeneic Transplantation in Case of Preventive Anti-CMV Treatment With Letermovir.
- Record updated
- 9 November 2026