Recruiting

Phase 3

LetermovirA Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients

Sponsor:

Children's Oncology Group

Code:

NCT05711667

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Letermovir

Study Details

Brief summary:

This phase III single arm trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant compared to estimated rate of infection without prophylaxis. The treatments used to prepare for HCT reduce the body's natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus. "Prophylaxis" means to take a drug to prevent a disease or side effect. Letermovir is an antiviral drug that stops cytomegalovirus from multiplying and may prevent cytomegalovirus infection and make the disease less severe.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Study ID

NCT05711667

Start date

Jul 11, 2024

Status verified date

Jan, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ARM A (Letermovir prophylaxis)

Patients receive letermovir PO or IV over 60 minutes QD starting on day +1 post-transplant for 14 weeks. Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.

active comparator: Arm B (No prophylaxis)

Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52. (CLOSED TO ACCURAL 09/29/2025)

Interventions

Biospecimen Collection

Undergo collection of blood samples

Letermovir

Given PO or IV

Primary outcome measure

Clinically significant cytomegalovirus (CMV) infection [ Time Frame: Up to week 14 post-transplant ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

205-638-9285 oncologyresearch@peds.uab.edu

Principal Investigator:

Joseph H. Chewning

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Site Public Contact

510-428-3264 PedOncRschOAK@ucsf.edu

Principal Investigator:

Jennifer G. Michlitsch

UCSF Medical Center-Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Site Public Contact

877-827-3222 cancertrials@ucsf.edu

Principal Investigator:

Lena E. Winestone

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

303-764-5056 josh.b.gordon@nsmtp.kp.org

Principal Investigator:

Sanam Shahid

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Sridhi Patel

Nemours Children's Clinic-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Sridhi Patel

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Site Public Contact

888-624-2778

Principal Investigator:

Ossama M. Maher

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Wade T. Kyono

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

800-248-1199

Principal Investigator:

April Rahrig

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Andrew P. Groves

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-629-5500 CancerResource@nortonhealthcare.org

Principal Investigator:

Michael J. Ferguson

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Site Public Contact

504-894-5377

Principal Investigator:

Maria C. Velez-Yanguas

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Site Public Contact

410-955-8804 jhcccro@jhmi.edu

Principal Investigator:

Heather J. Symons

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

helpdesk@childrensoncologygroup.org

Principal Investigator:

Erin Goode

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230 crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Site Public Contact

816-302-6808 COGResearchGroup@cmh.edu

Principal Investigator:

Lauren C. Wilson

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Shalini Shenoy

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777 ou-clinical-trials@ouhsc.edu

Principal Investigator:

Rene Y. McNall-Knapp

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

267-425-5544 CancerTrials@email.chop.edu

Principal Investigator:

Caitlin W. Elgarten

The Children's Hospital at TriStar Centennial

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Site Public Contact

615-342-1919

Principal Investigator:

Clinton M. Carroll

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Carrie L. Kitko

Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75230

Contacts

Site Public Contact

972-566-5588

Principal Investigator:

Maurizio L. Ghisoli

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097 canceranswerline@UTSouthwestern.edu

Principal Investigator:

Victor M. Aquino

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354 burton@bcm.edu

Principal Investigator:

Anil George

Methodist Children's Hospital of South Texas

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Public Contact

210-575-6240 Vinod.GidvaniDiaz@hcahealthcare.com

Principal Investigator:

Jose M. Esquilin

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Site Public Contact

801-585-5270

Principal Investigator:

Soohee Cho

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

800-622-8922 clinicaltrials@cancer.wisc.edu

Principal Investigator:

Christian M. Capitini

More Information

Sponsor

Children's Oncology Group

Last update posted

May 5, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2026-05-05.