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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Allogeneic HCT recipients with positive CMV serostatus

On letermovir prophylaxis at day 90 post transplant (+/- 7 days)

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)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hematopoietic Cell Transplant

    Procedure/Surgery

    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

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: Interrupted letermovir prophylaxisExperimental treatment 2 interventions
Group B: Standard letermovir prophylaxisExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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