NCT06639854 · M.D. Anderson Cancer Center
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
What this study is about
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.
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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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Not able to procure letermovir for extended prophylaxis beyond day +100.
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations