Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Results posted: Oct 14, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints revised (6)
    • Primary endpoint revised
    • Site details revised at 1 of 6 sites
  2. Primary completion date changed from estimate of Oct 31, 2025 to Sep 29, 2025v39
  3. Trial status: Recruiting to Active, Not Recruitingv38 Show 5 more changesShow less
    • Enrollment target: estimated 50 to confirmed 51
    • Primary completion date: Dec 31, 2025 to Oct 31, 2025
    • Study completion date: Jan 31, 2027 to Apr 30, 2027
    • Start date: Dec 12, 2020 to Dec 11, 2020
    • Site details revised at 6 of 6 sites
  4. Site contacts updated at 1 of 6 sitesv37
  5. Primary completion date: Aug 31, 2025 to Dec 31, 2025v36
Show 34 earlier versionsHide 34 earlier versions
  1. Primary completion date: Jan 31, 2025 to Aug 31, 2025v35
  2. Eligibility criteria shortened, about 38 words
    • Site contacts updated at 1 of 6 sites
    v34
  3. Site contacts updated at 1 of 6 sitesv33
  4. Re-verified, no change to tracked fieldsv32
  5. Site details revised at 1 of 6 sitesv31
  6. Site details revised at 1 of 6 sitesv30
  7. Primary completion date: Jan 31, 2023 to Jan 31, 2025
    • Study completion date: Jan 31, 2025 to Jan 31, 2027
    v29
  8. Site details revised at 1 of 6 sitesv28
  9. Study sites: 4 to 6v27
  10. Site details revised at 1 of 4 sitesv26
  11. Re-verified, no change to tracked fieldsv25
  12. Site details revised at 1 of 4 sitesv24
  13. Primary completion date: Jun 30, 2023 to Jan 31, 2023v23 Show 4 more changesShow less
    • Study completion date: Jun 30, 2025 to Jan 31, 2025
    • Start date: Dec 10, 2020 to Dec 12, 2020
    • Site contacts updated at 1 of 4 sites
    • Collaborators: 2 to 1
  14. Site details revised at 1 of 4 sitesv22
  15. Primary completion date: Oct 21, 2022 to Jun 30, 2023
    • Study completion date: Oct 21, 2024 to Jun 30, 2025
    • Start date changed from estimate of Apr 19, 2021 to Dec 10, 2020
    v21
  16. Start date: Mar 19, 2021 to Apr 19, 2021v20
  17. Start date: Feb 19, 2021 to Mar 19, 2021v19
  18. Start date: Jan 14, 2021 to Feb 19, 2021v18
  19. Start date: Dec 13, 2020 to Jan 14, 2021v17
  20. Start date: Nov 12, 2020 to Dec 13, 2020v16
  21. Start date: Oct 10, 2020 to Nov 12, 2020v15
  22. Eligibility criteria expanded, about 7 wordsv14
  23. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 8, 2020 to Oct 10, 2020
    • Site details revised at 4 of 4 sites
    v13
  24. Start date: Sep 3, 2020 to Sep 8, 2020v12
  25. Start date: Aug 1, 2020 to Sep 3, 2020v11
  26. Start date: Jul 1, 2020 to Aug 1, 2020v10
  27. Start date: May 30, 2020 to Jul 1, 2020v9
  28. Start date: Apr 30, 2020 to May 30, 2020v8
  29. Start date: Mar 17, 2020 to Apr 30, 2020v7
  30. Primary endpoint revisedv6
  31. 2 versions Re-verified since Feb 26, 2020, no change to tracked fieldsv4-v5
  32. Start date: Feb 2, 2020 to Mar 17, 2020v3
  33. Start date: Jan 1, 2020 to Feb 2, 2020v2
  1. Study First Submitted
  • 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 II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.
Trial Details
NCT Number NCT04198922
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Recurrent Moderate-Severe Chronic Graft Versus Host Disease, Hematopoietic and Lymphoid Cell Neoplasm
Related terms Hematologic Neoplasms
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov