Testing a T Cell Immunity Test to Guide Prolonged Use of Letermovir After Stem Cell Transplant

CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation

This study is testing whether a special blood test for T cell immunity can help doctors decide how long to keep giving letermovir to patients after a stem cell transplant to prevent a virus called CMV from coming back.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Locations: 5 sites (Wuhan, Hubei and 4 other locations)
• Trial ID: NCT06449586 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a CMV-specific T cell immunity test in determining the prolonged use of letermovir to prevent late-onset cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The research aims to address the increased risk of CMV reactivation following the discontinuation of letermovir, particularly in patients with low levels of CMV-specific T cells. By conducting a multicenter, randomized, controlled trial, the investigators seek to validate their previous findings and improve patient outcomes through tailored prophylaxis. Participants will be monitored for CMV-specific T cell recovery and the incidence of clinically significant CMV infections.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 who are undergoing their first allogeneic hematopoietic stem cell transplantation and are CMV IgG positive.

Not a fit: Patients with a history of CMV disease, organ failure, or those deemed unsuitable by the investigator may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of late-onset CMV infections in patients undergoing allo-HSCT.

How similar studies have performed: Previous studies have indicated that monitoring CMV-specific T cell levels can impact the management of CMV prophylaxis, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* first allogeneic hematopoietic stem cell transplantation;
* 18-70 years old;
* use cytomegalovirus prophylaxis with letemovir after allo-HSCT;
* CMV Ig G D+/R+;

Exclusion Criteria:

* Allergy, known hypersensitivity to letermovir tablet or injection components;
* CMV DNAemia within six months before transplantation or previous CMV disease;
* Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation;
* Second transplantation;
* Combination of immunodeficiency diseases;
* Those judged by the investigator to be unsuitable for participation in this trial.

Where this trial is running

Wuhan, Hubei and 4 other locations

• Tongji Hospital of Huazhong University of Science and Technology, Wuhan — Wuhan, Hubei, China (RECRUITING)
• Ruijin Hospital of Shanghai Jiaotong University — Shanghai, Shanghai, China (RECRUITING)
• The First Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• Ruijin Hospital, Shanghai JiaoTong University School of Medicine — Shanghai, China (RECRUITING)
• Shanghai Liquan Hospital — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Xiaoxia Hu

Conditions: Hematologic Malignancy