RecruitingNot ApplicableNCT06639854

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

105 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Hematopoietic Cell Transplant Cytomegalovirus Cell Mediated Immunity

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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

Exclusion Criteria5

Patients under the age of 18
Patients are discharged from our institution and unwilling to come back for follow up
Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
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.

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Interventions

PROCEDUREHematopoietic 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.

DRUGLetermovir

Given by PO