Letermovir to prevent cytomegalovirus after pediatric stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, single-arm trial gives prophylactic letermovir to CMV IgG–positive children and adolescents (ages 2 to under 18 years) undergoing allogeneic hematopoietic cell transplant to determine the incidence of clinically significant CMV infection through about 14 weeks (~100 days) post-transplant. The primary endpoint is clinically significant CMV infection through Week 14 and the key secondary endpoint is CMV-free survival through 24 weeks (~6 months). Exploratory outcomes include CMV incidence through 24 and 52 weeks, overall survival, time to engraftment, selected kidney and neutropenia-related adverse events, antiviral resistance patterns, and measures of immune reconstitution. Participants must weigh at least 6 kg and be treated at participating centers able to perform timely plasma CMV PCR monitoring.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital of Alabama
  Birmingham, Alabama, United States Recruiting
• UCSF Benioff Children's Hospital Oakland
  Oakland, California, United States Recruiting
• UCSF Medical Center-Mission Bay
  San Francisco, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Alfred I duPont Hospital for Children
  Wilmington, Delaware, United States Recruiting
• Nemours Children's Clinic-Jacksonville
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Caitlin W Elgarten — Children's Oncology Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.