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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06639854
Status
Recruiting
Apply to this trial

Conditions

  • Cytomegalovirus Cell Mediated Immunity
  • Hematopoietic Cell Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hematopoietic Cell Transplant — PROCEDURE
    Participants choices may include to receive standard post-transplant virus prevention with letermovir or other standard drugs without being part of this study. Participants may choose to receive other investigational therapy, if available. These alternative treatments have risks and benefits that may be the same or different than those in this research study.
  • Letermovir — DRUG
    Given by PO

Study Details

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.

Key Dates

Start date
Nov 20, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Interrupted letermovir prophylaxis
    Participants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV.
  • Experimental: Standard letermovir prophylaxis
    Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.

Primary Outcome Measure

Safety and Adverse Events (AEs). [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Fareed Khawaja, MBBS
[email protected]
281-610-0253
Fareed Khawaja, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas MD Anderson Cancer Center· Houston, TX

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