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Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis

Study acronym: ABA3
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 14 to 15v21
  2. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 14 of 14 sites
    v20
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Feb 2027 to May 2027
    • Site details revised at 14 of 14 sites
    v19
  4. Primary completion date: Apr 2025 to Feb 2027
    • Study completion date: Apr 2025 to Jun 2028
    • Site contacts updated at 1 of 14 sites
    v18
  5. Study sites: 13 to 14v17
Show 15 earlier versionsHide 15 earlier versions
  1. Primary completion date: Apr 2024 to Apr 2025
    • Study sites: 11 to 13
    v16
  2. Study sites: 9 to 11v15
  3. Site contacts updated at 1 of 9 sitesv14
  4. Site contacts updated at 1 of 9 sitesv13
  5. Study sites: 8 to 9v12
  6. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised at 8 of 8 sites
    v11
  7. Trial status: Not Yet Recruiting to Enrolling by Invitationv10 Show 4 more changesShow less
    • Primary completion date: Mar 2024 to Apr 2024
    • Study completion date: Mar 2025 to Apr 2025
    • Start date changed from estimate of Mar 2022 to Mar 30, 2022
    • Site contacts updated at 7 of 8 sites
  8. Study sites: 1 to 8v9 Show 4 more changesShow less
    • Primary completion date: Feb 2024 to Mar 2024
    • Study completion date: Feb 2025 to Mar 2025
    • Start date: Feb 2022 to Mar 2022
    • Eligibility criteria expanded, about 40 words
  9. Start date: Dec 2021 to Feb 2022v8
  10. Start date: Sep 2021 to Dec 2021
    • Primary completion date: Nov 2023 to Feb 2024
    • Study completion date: Dec 2024 to Feb 2025
    v7
  11. Start date: Jun 2021 to Sep 2021v6
  12. Start date: Apr 2021 to Jun 2021v5
  13. Start date: Jan 2021 to Apr 2021
    • Primary completion date: Aug 2023 to Nov 2023
    • Study completion date: Sep 2024 to Dec 2024
    v4
  14. Start date: Jul 2020 to Jan 2021v3
  15. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant.
Trial Details
NCT Number NCT04380740
Lead Sponsor Boston Children's Hospital
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Graft Vs Host Disease
Related terms Graft vs Host Disease
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov