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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Children's Oncology Group to Children's Oncology Group Trial sites expanded: 29 → 33 locations · Secondary endpoints: details revised at 1 of 2 entries · Study description revised · 1 more Show 4 more changesShow less
    • Trial sites expanded: 29 → 33 locations
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    • Eligibility criteria expanded, about 5 words
  2. Study sites: 28 to 29v22
  3. Study sites: 22 to 28v21
  4. Eligibility criteria shortened, about 11 words Secondary endpoints: details revised at 2 of 2 entries · Study description expanded, about 12 words · Site details revised at 4 of 22 sitesv20 Show 3 more changesShow less
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 12 words
    • Site details revised at 4 of 22 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 2 of 22 sitesv19
Show 17 earlier versionsHide 17 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting Study sites: 19 to 22v18 Show 1 more changeShow less
    • Study sites: 19 to 22
  2. Primary and study completion dates: Jun 1, 2028 to Jun 30, 2029 Start date: May 20, 2024 to Jul 11, 2024 · Enrollment target: 143 to 105 · Study description shortened, about 58 wordsv17 Show 3 more changesShow less
    • Start date: May 20, 2024 to Jul 11, 2024
    • Enrollment target: 143 to 105
    • Study description shortened, about 58 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv16
  4. Study sites revised (19)v15 See this version in full on ClinicalTrials.gov ↗
  5. 2 versions Re-verified since Feb 11, 2025, no change to tracked fieldsv13-v14
  6. Trial status: Recruiting to Active, Not Recruiting Study sites: 17 to 19v12 Show 1 more changeShow less
    • Study sites: 17 to 19
  7. Study sites: 14 to 17v11
  8. Study sites: 11 to 14v10
  9. Study sites: 10 to 11 Secondary endpoints: details revised at 2 of 2 entriesv9 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 2 entries
  10. Primary endpoint revised Study sites: 4 to 10 · Secondary endpoints revised (2)v8 Show 2 more changesShow less
    • Study sites: 4 to 10
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 2 to 4v7
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Apr 29, 2024 to May 20, 2024v6 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Apr 29, 2024 to May 20, 2024
  13. Start date: Jan 26, 2024 to Apr 29, 2024v5
  14. Start date: Aug 23, 2023 to Jan 26, 2024v4
  15. Start date: Aug 20, 2023 to Aug 23, 2023v3
  16. Start date: Jun 17, 2023 to Aug 20, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05711667
Lead Sponsor Children's Oncology Group
Conditions Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov