The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
NCT ID: NCT06639854
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
105 participants
INTERVENTIONAL
2024-11-20
2026-12-31
Brief Summary
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Detailed Description
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•To compare the proportion of CS-CMVi in allo-HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis up to 200 days post transplantation.
Secondary Objectives
* To compare the proportion of CS-CMVi in HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis at 365 days post transplantation.
* To compare the overall use of letermovir in HCT recipients in both arms.
* To compare CMV CMI in HCT recipients in both arms.
* To compare all-cause mortality and nonrelapse mortality between the 2 arms at day +200 and day +365.
* Healthcare expenditures for letermovir use and TCIP for both arms from day +100 to day +200.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Hematopoietic Cell Transplant
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
Given by PO
Standard letermovir prophylaxis
Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.
Hematopoietic Cell Transplant
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
Given by PO
Interventions
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Hematopoietic Cell Transplant
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
Given by PO
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Fareed Khawaja, MBBS
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Fareed Khawaja, MBBS
Role: primary
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2024-08626
Identifier Type: OTHER
Identifier Source: secondary_id
2024-1144
Identifier Type: -
Identifier Source: org_study_id