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Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv14
  2. Eligibility criteria shortened, about 12 wordsv13 See this version in full on ClinicalTrials.gov ↗
  3. Eligibility criteria expanded, about 65 words Site contact updatedv12 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv11
  5. Site contact updatedv10
Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Trial status: Active, Not Recruiting to Recruiting Primary and study completion dates: Aug 2027 to Aug 31, 2028 · Study description revised · Site details revisedv8 Show 3 more changesShow less
    • Primary and study completion dates: Aug 2027 to Aug 31, 2028
    • Study description revised
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
  4. Primary completion date: Nov 2027 to Aug 2027 Completion date: Mar 2028 to Aug 2027v6 Show 1 more changeShow less
    • Completion date: Mar 2028 to Aug 2027
  5. Re-verified, no change to tracked fieldsv5
  6. Start date changed from estimate of Jan 2023 to Jan 11, 2023v4
  7. Start date: Nov 2022 to Jan 2023 Primary completion date: Sep 2027 to Nov 2027 · Completion date: Jan 2028 to Mar 2028v3 Show 2 more changesShow less
    • Primary completion date: Sep 2027 to Nov 2027
    • Completion date: Jan 2028 to Mar 2028
  8. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2022 to Nov 2022 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: Sep 2022 to Nov 2022
    • Study sites: 0 to 1
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Alemtuzumab is an antibody that reduces the strength of the immune system that is given in preparation for allogeneic hematopoietic cell transplant (HCT). In this research study the investigators want to find out if they can adjust the dose of alemtuzumab used as part of allogeneic HCT to target the level of Day 0 (the planned day of graft infusion) to an optimal therapeutic window of 0.15-0.9 ug/mL.
Trial Details
NCT Number NCT05501756
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Conditions Allogeneic Hematopoietic Cell Transplantation
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov