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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Hematopoietic Cell Transplant
Procedure/SurgeryParticipants 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
DrugGiven by PO
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.