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NCT05711667 · ClinicalTrials.gov registry record · Phase 3
A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients
A Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT05711667: Recruiting Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Children's Oncology Group.
NCT05711667 is a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 105 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05711667, a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Clinically significant CMV is defined as the first of (1) initiation of anti-CMV preemptive therapy for documented CMV DNAemia or (2) onset of CMV end-organ disease. Will estimate the cumulative incidence of clinically significant CMV at 14-weeks post-transplant and will report the corresponding 95% confidence interval.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Letermovir
Study Locations (20)
California
- UCSF Benioff Children's Hospital Oakland - Oakland
- UCSF Medical Center-Mission Bay - San Francisco
Florida
- Nemours Children's Clinic-Jacksonville - Jacksonville
- Nicklaus Children's Hospital - Miami
Michigan
- Children's Hospital of Michigan - Detroit
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital - Grand Rapids
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
- Washington University School of Medicine - St Louis
Tennessee
- Saint Jude Children's Research Hospital - Memphis
- The Children's Hospital at TriStar Centennial - Nashville
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
What NCT05711667 shows while recruiting
NCT05711667 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT05711667 names 20 study sites across 15 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05711667 about?
NCT05711667 is a clinical study titled "A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients". 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 ...
What is the current status of trial NCT05711667?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2024-07-11. Estimated completion is 2029-06-30.
What conditions does trial NCT05711667 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm.
What interventions are being tested in trial NCT05711667?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Letermovir (DRUG).
Who is sponsoring clinical trial NCT05711667?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05711667 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05711667's enrollment target sits among peer trials
105 89th of 176 higher than 88 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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