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Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Completed to Active, Not Recruiting
    • Study completion date: Jun 24, 2024 to Jun 2025
    v7
  2. Start date: Mar 11, 2020 to May 18, 2020v6 Show 7 more changesShow less
    • Trial status: Recruiting to Completed
    • Enrollment target: estimated 72 to confirmed 24
    • Study sites: 5 to 4
    • Primary completion date changed from estimate of Apr 30, 2024 to Jun 24, 2024
    • Study completion date changed from estimate of Mar 31, 2025 to Jun 24, 2024
    • Secondary endpoints revised (9)
    • Collaborators revised (3)
  3. Primary completion date: Jan 2023 to Apr 30, 2024v5 Show 4 more changesShow less
    • Study sites: 3 to 5
    • Study completion date: Jan 2024 to Mar 31, 2025
    • Eligibility criteria expanded, about 21 words
    • Collaborators revised (3)
  4. Study sites: 2 to 3v4
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v3
  6. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Feb 2020 to Mar 11, 2020
    • Site contacts updated at 2 of 2 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a single arm phase 2 trial which includes patients with high risk acute GVHD defined as Ann Arbor score 2 or 3. The purpose of the study is to improve the outcome of these patients in terms of response to treatment and treatment related mortality. All patients will receive the study intervention (ECP with Uvadex). The study hypothesis is that the treatment plan will produce a day 28 complete response rate higher than or equal to 52%, which will represent an improvement of 15% compared with the standard of care (37%). The rate of complete response to standard of care treatment is based on observed data in similar patients treated within the Mount Sanai Acute GVHD International Consorium (MAGIC). Patients will be treated for 56 days and followed for one year to also enable evaluation of long term outcome.
Trial Details
NCT Number NCT04291261
Lead Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators: Therakos, University Hospital Regensburg, Arbeitskreis Klinische Forschung PD Dr. med. Seiler GmbH
Conditions
(from sponsor)		 Acute-graft-versus-host Disease
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov