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CMVPhase 2NCT04017962

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

A Phase 2 study testing Letermovir Pill and blood draw in people with CMV and CMV Infection, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
CMV, CMV Infection, Hematopoietic Cell Transplant
What is being tested?
Letermovir Pill and blood draw
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesUnited States
Study dates
19 Jul 2019to 29 Jul 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age >/= 12 years (any weight)
  • Have received allogenic HCT
  • Have received preemptive therapy for clinically significant CMV infection post-HCT and have completed preemptive therapy no longer than 7 days prior to enrollment. Preemptive treatment includes ganciclovir, valganciclovir, foscarnet or cidofovir. Clinically significant CMV infection is defined as CMV viremia requiring preemptive therapy or CMV EOD. Patients who have received LTV prophylaxis prior to onset of clinically significant CMV infection prior to enrollment (see also exclusion criteria below).
  • 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
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  • 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

Who cannot join

  • Clinically significant CMV infection present at enrollment
  • Breakthrough CMV infection while on primary LTV prophylaxis (unless patient non-adherent or unable to adequately absorb letermovir or documented resistance to LTV.
  • Glomerular filtration rate (GFR) </= mL/min/1.73m^2(equivalent to creatinine clearance </=10 mL/min)
  • Severe hepatic impairment
  • Routine use of high-dose acyclovir (doses of > 800 mg twice daily), valacyclovir (doses of > 500mg twice daily), or famciclovir (doses > 500mg/day) for varicella zoster virus (VZV)/herpes simplex virus prophylaxis; limited treatment courses at higher doses for VZV infections are permissible if treatment duration dose not exceed 14 days total. Short courses of IV cidofovir for adeno virus (ADV) are permissible
  • Suspected or known hypersensitivity to active or inactive ingredients of LTV formulations
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  • Patients treated with a medication whose administration with LTV is ontraindicated and whose discontinuation is not possible. Contraindicated medications include pimozide, ergot alkaloids and pitavastatin or simvastatin when co-administered with cyclosporine.
  • Imminent demise (expected survival <6 weeks)
  • Documented positive result for human immunodeficiency virus antibody (HIV-Ab) or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) at any time prior to HCT
  • Need for mechanical ventilation and/or vasopressor support at the time of enrollment
  • Pregnancy or breastfeeding
  • Plans to conceive or father children within the projected duration of the trial
  • History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study.
  • The following antivirals are allowed up to the listed dose limits:
  • Acyclovir up to 800 mg twice daily
  • Valacyclovir up to 500 mg twice daily
  • Famciclovir up to 500 mg/day for VZV/HSV prophylaxis; limited treatment courses at higher doses for VZV infections are permissible if treatment duration does not exceed 14 days total.
  • Short courses of IV cidofovir for ADV (up to two doses)
  • Clinically significant CMV infection during the 100 days following HCT. Clinically significant CMV infection defined as either CMV viremia requiring preemptive therapy with CMV antivirals or CMV end organ disease (EOD)
  • Grade 3-4 GVHD
  • Cord blood as cell source for HCT
  • Treatment with systemic steroids (>0.5mg/kg for 2 weeks or longer) within 3 weeks prior to enrollment

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: An Open-label, Single-arm Study of Letermovir (LTV) for Prevention of Recurrent CMV Infection in High-risk Hematopoietic Cell Transplant (HCT) Recipients

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.

Being tested
Letermovir Pill, blood draw
Keywords
HCT, CMV infection, Letermovir, LTV, Memorial Sloan Kettering Cancer Center, 19-174
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Letermovir PillDrug

    Also called LTV

    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.

  • blood drawOther

    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.

Study groups in NCT04017962
Study groupRoleWhat they receive
Hematopoietic cell transplantation/HCTExperimentalParticipants 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.
Receives: Drug: Letermovir Pill; Other: blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 weeks

Secondary outcomes (4)

  1. 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

    Emergence of Letermovir-resistant CMV Virus in Patients with breakthrough clinically significant CMV viremia.

    Measured: 14 weeks

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

    Measured: 14 weeks

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

    Measured: 14 weeks

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

    Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2019
  2. Study start19 Jul 2019
  3. Primary completion7 Aug 2024
  4. Study completion29 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04017962
Sponsor's protocol ID
19-174
Status last verified
Jul 2025
First submitted
10 Jul 2019
Last updated
11 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letermovir Pill and blood draw in people with CMV and CMV Infection, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically Significant CMV Viremia for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04017962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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