Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06639854

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 2025-11-06

105

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Allogeneic hematopoietic cell transplant recipients with positive CMV serostatus
  • Receiving letermovir prophylaxis around day 90 post transplant (+/- 7 days)
  • At high risk for CMV reactivation after day 100, including any of the following:
    • Prior or active graft versus host disease requiring systemic steroids
    • Mismatch stem cell donor (haploidentical, mismatch unrelated donor, match related donor with one mismatch at HLA-A, HLA-B, or HLA-DR, or cord donor recipients)
    • Received T cell depletion or anti-thymoglobulin during conditioning
    • CMV reactivation prior to day 100 post transplant
    • Use of steroids at any dose within 2 weeks of enrollment
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Discharged from the institution and unwilling to return for follow-up
  • Actively undergoing treatment for clinically significant CMV infection at screening
  • Allergic or intolerant to letermovir or with 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

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Trial Site Locations

Total: 1 location

1

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

F

Fareed Khawaja, MBBS

CONTACT

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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The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients | DecenTrialz