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New hope: drug may shield kids from virus after transplant

NCT ID NCT05711667

Disease control Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether the antiviral drug letermovir can prevent cytomegalovirus (CMV) infection in children and teens who have had a stem cell transplant. About 105 participants aged 2 to 17 will receive letermovir and be monitored for 14 weeks. The goal is to see if the drug lowers the chance of serious CMV infection compared to expected rates without it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Letermovir (an antiviral drug)
What this could lead to
If it works, this could provide a safe way to prevent CMV infection in children after stem cell transplant, reducing hospital stays and severe illness.
What could go wrong
This is a single-arm trial with no placebo group, so results may be less definitive. The drug may still fail to prevent CMV or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \>= 2 years and \< 18 years at the time of enrollment * Weight must be \>= 6 kg at the time of enrollment * Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant) * Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive) * Note: If a patient has hypogammaglobulinemia but has previously been documented as CMV sero-positive, that is acceptable for study inclusion. For all patients already confirmed to be CMV IgG seropositive, repeat testing is not required within 7 days prior to enrollment. However, the laboratory data determining eligibility must be available in the patient's medical/research record for verification * Patient is eligible for entry only if it is feasible for plasma CMV PCR testing to be sent and resulted within the protocol mandated time period * Reminder: To limit the likelihood of positive plasma CMV PCR post-enrollment and prior to start of study treatment period, it is recommended that patient enrollment proceed after patients start their transplant preparative regimen * Patient must have a performance status corresponding to Lansky/Karnofsky scores \> 50 * Note: Use Lansky for patients =\< 16 years of age and Karnofsky for patients \> 16 years of age. For further reference, see performance status scales scoring under the standard sections for protocols among protocol reference materials provided on the Children's Oncology Group (COG) member website: https://members.childrensoncologygroup.org/prot/reference\_materials.asp * Estimated glomerular filtration rate \> 10 mL/min/1.73 m\^2 and not receiving dialysis * Direct bilirubin =\< 2 mg/dL and serum glutamate-pyruvate transaminase (SPGT) (alanine transaminase \[ALT\]) =\<10 x upper limit of normal (ULN) for age * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L Exclusion Criteria: * Expected inability to tolerate oral formulation of letermovir * Hypersensitivity to letermovir or any component of the formulation * History of CMV end organ disease within 6 months (180 days) prior to enrollment * Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease * Receipt of prior allogeneic HCT within one year of study enrollment * Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including: * High dose acyclovir (defined as doses \>= 1500 mg/m\^2 IV or \>= 3200 mg oral (patients \>= 40 kg) or \>= 2400 mg/m\^2 (patients \< 40 kg) per day) * High dose valacyclovir (defined as doses \>= 3000 mg/day in patients \> 20 kg) * Foscarnet * Ganciclovir * Valganciclovir * CMV-directed cytotoxic T lymphocytes * Planned receipt of the following contraindicated medications during the study treatment period; contraindicated medications must be discontinued at least 14 days prior to Day +1 * Contraindicated medications for all patients: * Pimozide * Ergot alkaloids * Contraindicated medications for patients planned to receive cyclosporine: * Bosentan * Pitavastatin * Simvastatin * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted in certain animal reproduction studies with letermovir. A pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active female patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their letermovir treatment and through at least 4 weeks after the last dose of letermovir. * Note: No contraception measures are needed specifically during letermovir treatment for male trial participants who have pregnant or non-pregnant female partner(s) of reproductive potential. Contraception measures may be required for other aspects of the HCT procedure. * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

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Conditions

The condition(s) this trial relates to.

cancer hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm cytomegalovirus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic and lymphoid cell neoplasm Malignant solid neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alfred I duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital New Orleans

    RECRUITING

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

    Contact Email: •••••@•••••

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kapiolani Medical Center for Women and Children

    RECRUITING

    Honolulu, Hawaii, 96826, United States

  • Medical City Dallas Hospital

    RECRUITING

    Dallas, Texas, 75230, United States

  • Methodist Children's Hospital of South Texas

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Nemours Children's Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

    Contact Email: •••••@•••••

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Saint Jude Children's Research Hospital

    ACTIVE_NOT_RECRUITING

    Memphis, Tennessee, 38105, United States

  • The Children's Hospital at TriStar Centennial

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UCSF Benioff Children's Hospital Oakland

    RECRUITING

    Oakland, California, 94609, United States

  • UCSF Medical Center-Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • University of Iowa/Holden Comprehensive Cancer Center

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Richmond, Virginia, 23298, United States

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

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