Cytomegalic Inclusion Disease Clinical Trials

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Letermovir Prophylaxis for Cytomegalovirus in Pediatric Hematopoietic Cell Transplantation

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

• \>= 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

Locations
United States
Alabama
Children's Hospital of Alabama
RECRUITING
Birmingham
California
UCSF Benioff Children's Hospital Oakland
RECRUITING
Oakland
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Delaware
Alfred I duPont Hospital for Children
RECRUITING
Wilmington
Florida
Nemours Children's Clinic-Jacksonville
RECRUITING
Jacksonville
Nicklaus Children's Hospital
RECRUITING
Miami
Iowa
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING
Iowa City
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Kentucky
Norton Children's Hospital
RECRUITING
Louisville
Louisiana
Children's Hospital New Orleans
RECRUITING
New Orleans
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Michigan
Children's Hospital of Michigan
RECRUITING
Detroit
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Missouri
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
Washington University School of Medicine
RECRUITING
St Louis
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Tennessee
Saint Jude Children's Research Hospital
ACTIVE_NOT_RECRUITING
Memphis
The Children's Hospital at TriStar Centennial
RECRUITING
Nashville
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Texas
Medical City Dallas Hospital
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
Methodist Children's Hospital of South Texas
RECRUITING
San Antonio
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Virginia
VCU Massey Comprehensive Cancer Center
NOT_YET_RECRUITING
Richmond
Wisconsin
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 105
Treatments
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)
Sponsors
Leads: Children's Oncology Group

This content was sourced from clinicaltrials.gov