Recruiting

Leterovir

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06639854

Conditions

Cytomegalovirus Cell Mediated Immunity

Hematopoietic Cell Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hematopoietic Cell Transplant

Letermovir

Study Details

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

Study ID

NCT06639854

Start date

Nov 20, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Fareed Khawaja, MBBS

(281) 610-0253fkhawaja@mdanderson.org

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Fareed Khawaja, MBBS

281-610-0253fkhawaja@mdanderson.org

Principal Investigator:

Fareed Khawaja, MBBS

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-15.