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Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Dec 30, 2026 to Dec 30, 2027v8
  2. Primary completion date: Jan 30, 2025 to Dec 30, 2026v7
  3. Re-verified, no change to tracked fieldsv6
  4. Primary completion date: Jan 30, 2024 to Jan 30, 2025
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 23, 2022 to Nov 9, 2022
    • Study title shortened, about 1 word
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Sep 23, 2022 to Dec 23, 2022
    • Primary completion date: Dec 30, 2023 to Jan 30, 2024
    v3
  2. Primary endpoint revisedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.
Trial Details
NCT Number NCT05509933
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)		 Engraftment Syndrome
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov