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

NCT06639854 | Recruiting

• 2 other identifiers: 2024-1144NCI-2024-08626
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cytomegalovirus Cell Mediated Immunity; Hematopoietic Cell Transplant

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs).

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (2)

Interrupted letermovir prophylaxis

EXPERIMENTAL

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.

Procedure: Hematopoietic Cell Transplant; Drug: Letermovir

Standard letermovir prophylaxis

EXPERIMENTAL

Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.

Procedure: Hematopoietic Cell Transplant; Drug: Letermovir

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.

Interrupted letermovir prophylaxis; Standard letermovir prophylaxis

Letermovir DRUG

Given by PO

Interrupted letermovir prophylaxis; Standard letermovir prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under the age of 18
• Patients are discharged from our institution and unwilling to come back for follow up
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

letermovir

Study Officials

• Fareed Khawaja, MBBS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fareed Khawaja, MBBS

CONTACT

(281) 610-0253; fkhawaja@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)