A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection

NCT04017962 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-174
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant.

Conditions

CMV; CMV Infection; Hematopoietic Cell Transplant

Keywords

HCT; CMV infection; Letermovir; LTV; Memorial Sloan Kettering Cancer Center; 19-174

Outcome Measures

Primary Outcomes (1)

• Clinically Significant CMV Viremia for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only

  Clinically significant CMV viremia defined as: Any level CMV DNAemia requiring preemptive treatment per Institutional standard of care at each participating Institution.

  14 weeks

Secondary Outcomes (4)

• Number of Participants With Breakthrough Clinically Significant CMV Viremia With Emergence of Letermovir-resistant CMV Virus for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only

  14 weeks

• CMV End Organ Disease for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only

  14 weeks

• CMV Related Death for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only

  14 weeks

• Adverse Events at Least Possibly Related to Letermovir by the Treating Physician for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only

  14 weeks

Study Arms (1)

Hematopoietic cell transplantation/HCT

EXPERIMENTAL

Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. OBSERVATIONAL COHORT: Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.

Drug: Letermovir Pill; Other: blood draw

Interventions

Letermovir Pill DRUG

Patients enrolled on the study will receive oral LTV 480 mg daily (240 mg daily for patients receiving cyclosporine A). The maximum duration of LTV administration will be 14 weeks. Patients receiving oral medication will be administered a pill diary for drug compliance purposes. This will be administered and reconciled in clinic.

Also known as: LTV

Hematopoietic cell transplantation/HCT

blood draw OTHER

Collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.

Hematopoietic cell transplantation/HCT

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 12 years (any weight)
• Have received allogenic HCT

You may not qualify if:

• Have one or more risk factors for recurrent CMV infection:
• Human leukocyte antigen (HLA) mismatch
• HLA-related (sibling) donor with at least one mismatch at the HLA-A, -B or -DR gene loci
• Haploidentical donor
• Unrelated donor with at least one mismatch at the HLA-A, -B, -C or -DRC1gene loci, or
• Cord blood as stem cell source
• Acute or chronic GVHD requiring either topical steroids for gastrointestinal GVHD and/or systemic steroid treatment (\>/= 1mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 14 days prior to enrollment
• T-cell-depleted allograft ex-vivo or in-vivo T-cell depleting agents including but not limited to ATG, alemtuzimab and post HCT cyclophosphamide.
• For adult patients, able to provide written consent and complete the informed consent. For patients under 18 years, the patient's parent(s) or legal guardian(s) must provide informed consent and the patient must provide written assent to participation in the study.
• Willing and able to comply with trial instructions and requirements
• Male and female patients of childbearing potential must be willing to use a highly effective method of contraception for the course of the study. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
• Subject eligibility criteria for the observational cohort:
• Age 18 years or older
• First allogenic peripheral blood or marrow HCT
• LTV prophylaxis starting \<30 days post HCT and given for at least 6 weeks

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Genovefa Papanicolaou, MD
• Organization: Memorial Sloan Kettering Cancer Center

papanicg@mskcc.org

212-639-6483

Study Officials

• Genovefa Papanicolaou

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: July 19, 2019
• Primary Completion: August 7, 2024
• Study Completion: July 29, 2025
• Last Updated: August 11, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)