The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophyla… (NCT06639854) | Clinical Trial Compass
RecruitingNot Applicable
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
United States105 participantsStarted 2024-11-20
Plain-language summary
The goal of this laboratory research study is to learn if interrupting a patient's letermovir dosing based on their immune system response can help HSC transplant patients avoid post-treatment CMV infections better than taking letermovir every day without interruption.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Allogeneic HCT recipients with positive CMV serostatus
✓. On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
✓. At high risk for CMV reactivation after day +100:
✓. Prior or active graft versus host disease requiring systemic steroids
✓. Mismatch stem cell donor (includes haploidentical, mismatch unrelated donor (MMUD), match related donor with at least one mismatch at one of the three specified HLA gene loci (HLA-A, HLA-B, or HLA-DR) and cord donor recipients)
✓. Received T cell depletion or anti thymoglobulin during conditioning
✓. CMV reactivation prior to day 100 post transplant
✓. On steroids at any dose within 2 weeks of enrollment
Exclusion criteria
✕. Patients under the age of 18
✕. Patients are discharged from our institution and unwilling to come back for follow up
✕. Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
✕. Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.
✕
What they're measuring
1
Safety and Adverse Events (AEs).
Timeframe: Through study completion; an average of 1 year.