Optimizing Letermovir Prophylaxis for Hematopoietic Cell Transplant Recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine whether interrupting letermovir prophylaxis based on a patient's immune response can reduce the incidence of cytomegalovirus (CMV) infections in hematopoietic cell transplant (HCT) recipients. The study compares two approaches: one where letermovir is administered continuously and another where it is interrupted based on cytomegalovirus cell-mediated immunity (CMI) assessments. The trial will evaluate the effectiveness of these strategies in preventing CMV reactivation and their impact on overall health outcomes, including mortality rates and healthcare costs. Participants will be monitored for up to 365 days post-transplant to assess the long-term effects of the interventions.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Allogeneic HCT recipients with positive CMV serostatus
2. On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
3. At high risk for CMV reactivation after day +100:

   1. Prior or active graft versus host disease requiring systemic steroids
   2. 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)
   3. Received T cell depletion or anti thymoglobulin during conditioning
   4. CMV reactivation prior to day 100 post transplant
   5. On steroids at any dose within 2 weeks of enrollment

Exclusion criteria

1. Patients under the age of 18
2. Patients are discharged from our institution and unwilling to come back for follow up
3. Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
4. Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.
5. Not able to procure letermovir for extended prophylaxis beyond day +100.

Where it's running

• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Fareed Khawaja, MBBS — M.D. Anderson Cancer Center
• Study coordinator: Fareed Khawaja, MBBS
• Email: fkhawaja@mdanderson.org
• Phone: (281) 610-0253

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.