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Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 12 words Study description expanded, about 3 words Show 1 more changeShow less
    • Study description expanded, about 3 words
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 29, 2025 to Apr 15, 2025 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Jun 29, 2025 to Apr 15, 2025
    • Site details revised
  3. Site contact updatedv5
  4. Primary completion date: Jan 29, 2026 to Dec 2026 Start date: Nov 29, 2024 to Jun 29, 2025 · Completion date: Apr 2027 to May 2027v4 Show 2 more changesShow less
    • Start date: Nov 29, 2024 to Jun 29, 2025
    • Completion date: Apr 2027 to May 2027
  5. Start date: Jun 29, 2024 to Nov 29, 2024 Primary completion date: Oct 29, 2025 to Jan 29, 2026 · Completion date: Feb 2027 to Apr 2027 · Site contact updatedv3 Show 3 more changesShow less
    • Primary completion date: Oct 29, 2025 to Jan 29, 2026
    • Completion date: Feb 2027 to Apr 2027
    • Site contact updated
  6. Start date: Apr 29, 2024 to Jun 29, 2024 Primary completion date: Aug 29, 2025 to Oct 29, 2025 · Completion date: Dec 31, 2026 to Feb 2027v2 Show 2 more changesShow less
    • Primary completion date: Aug 29, 2025 to Oct 29, 2025
    • Completion date: Dec 31, 2026 to Feb 2027
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD.
Trial Details
NCT Number NCT06315309
Lead Sponsor University of Alabama at Birmingham
Conditions GVHD,Acute, Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov