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NCT05711667RecruitingPhase 3

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

Letermovir Prophylaxis for Cytomegalovirus in Pediatric Hematopoietic Cell Transplantation

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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 hematopoietic cell transplant (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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
105 (estimated)
First submitted
23 Jan 2023
Start date
11 Jul 2024
Primary completion date
30 Jun 2029
Lead sponsor
Children's Oncology Group
NCT number
NCT05711667

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 105
  • From 11 Jul 2024 to the primary completion date, 30 Jun 2029
  • 33 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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

Other illness

  • Hypersensitivity to letermovir or any component of the formulation
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Lab values

  • 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

Other

  • Expected inability to tolerate oral formulation of letermovir
  • 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

Who the study is looking for

  • \>= 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

Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Children's Hospital of Alabama
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Nationwide Children's Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Medical City Dallas Hospital
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Children's Hospital of Michigan
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
Cook Children's Medical Center
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
Penn State Children's Hospital
Coordinator of this site? Confirm its status
HersheyUnited StatesRecruiting
Kapiolani Medical Center for Women and Children
Coordinator of this site? Confirm its status
HonoluluUnited StatesRecruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Riley Hospital for Children
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting
Nemours Children's Clinic-Jacksonville
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Children's Mercy Hospitals and Clinics
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Norton Children's Hospital
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Coordinator of this site? Confirm its status
MadisonUnited StatesRecruiting
Saint Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesActive, not recruiting
Nicklaus Children's Hospital
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Vanderbilt University/Ingram Cancer Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
The Children's Hospital at TriStar Centennial
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Children's Hospital New Orleans
Coordinator of this site? Confirm its status
New OrleansUnited StatesRecruiting
UCSF Benioff Children's Hospital Oakland
Coordinator of this site? Confirm its status
OaklandUnited StatesRecruiting
University of Oklahoma Health Sciences Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
Children's Hospital of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
Primary Children's Hospital
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
Methodist Children's Hospital of South Texas
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
UCSF Medical Center-Mission Bay
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
New York Medical College
Coordinator of this site? Confirm its status
ValhallaUnited StatesRecruiting
Alfred I duPont Hospital for Children
Coordinator of this site? Confirm its status
WilmingtonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.