Actively Recruiting
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
Led by M.D. Anderson Cancer Center · Updated on 2026-06-02
105
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether interrupting letermovir dosing based on a patient's immune response can help hematopoietic stem cell transplant (HCT) recipients better avoid cytomegalovirus (CMV) infections compared to taking letermovir every day without interruption. The study focuses on allogeneic HCT patients with positive CMV serostatus who are at high risk for CMV reactivation after day 100 post-transplant. It aims to compare rates of clinically significant CMV infection, overall letermovir use, immune response, mortality, and healthcare costs between the two approaches. Participants are randomly assigned to one of two groups. In the investigational group, participants start letermovir but may have their dosing paused if blood tests show their immune system is responding to CMV. The standard care group receives daily letermovir to prevent CMV infection without interruption. Letermovir is given by mouth, and the study treatment duration may extend up to 200 days post-transplant, with some outcomes measured up to 365 days. During the study, participants will have blood tests to monitor their immune response to CMV and clinical assessments for infection and safety. Researchers will track adverse events throughout the study, which lasts about one year. They will also evaluate mortality rates and healthcare use related to letermovir and other treatments. Follow-up visits will help ensure safety and assess the impact of different letermovir dosing strategies on CMV outcomes.
CONDITIONS
Brief Title
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Allogeneic hematopoietic cell transplant recipients with positive CMV serostatus
- On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
- At high risk for CMV reactivation after day 100, including one or more of the following: prior or active graft versus host disease requiring systemic steroids; mismatch stem cell donor; 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
You will not qualify if you...
- Patients under the age of 18
- Patients discharged from the institution and unwilling to return for follow-up
- Patients actively undergoing treatment for clinically significant CMV infection at screening
- Patients allergic or intolerant to letermovir or with a history of letermovir resistant CMV infection
- Unable to obtain letermovir for extended prophylaxis beyond day 100
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From day 90 post transplant up to 200 days post transplant
Participants receive letermovir prophylaxis to prevent cytomegalovirus (CMV) infection after hematopoietic cell transplant. Depending on the assigned group, participants either continue standard daily letermovir or have letermovir paused based on immune response to CMV.
Visits at least around day 90 and periodically up to day 200 to monitor immune response and medication status
Duration - Up to approximately 1 year from study start
Participants are monitored for safety, adverse events, and outcomes related to CMV infection and mortality after completion of letermovir prophylaxis.
Periodic visits for safety and outcome assessments
Trial Site Locations
Total: 1 location
1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Fareed Khawaja, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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