T-Guard (SPV-T3a-RTA/WT1-RTA) / Xenikos 
Welcome,         Profile    Billing    Logout  
 0 Diseases   0 Trials   0 Trials   3 News 
  • ||||||||||  T-Guard (SPV-T3a-RTA/WT1-RTA) / Xenikos
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002) (clinicaltrials.gov) -  Jan 25, 2023   
    P3,  N=12, Terminated, 
    No abstract available N=246 --> 12 | Trial completion date: Jun 2026 --> Jan 2023 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Nov 2022; The study met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib arms
  • ||||||||||  T-Guard (SPV-T3a-RTA/WT1-RTA) / Xenikos
    Trial completion date, Trial initiation date, Trial primary completion date:  A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002) (clinicaltrials.gov) -  Mar 21, 2022   
    P3,  N=246, Recruiting, 
    N=246 --> 12 | Trial completion date: Jun 2026 --> Jan 2023 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Nov 2022; The study met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib arms Trial completion date: Jan 2026 --> Apr 2026 | Initiation date: Dec 2021 --> Mar 2022 | Trial primary completion date: Jan 2025 --> Apr 2025
  • ||||||||||  T-Guard (SPV-T3a-RTA/WT1-RTA) / Xenikos
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802) (clinicaltrials.gov) -  Aug 27, 2020   
    P3,  N=3, Terminated, 
    Initiation date: Sep 2021 --> Dec 2021 N=47 --> 3 | Trial completion date: Sep 2021 --> Feb 2020 | Suspended --> Terminated | Trial primary completion date: Nov 2020 --> Feb 2020; Initiated a new randomized trial per discussion with FDA
  • ||||||||||  T-Guard (SPV-T3a-RTA/WT1-RTA) / Xenikos
    Trial suspension:  T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802) (clinicaltrials.gov) -  Mar 23, 2020   
    P3,  N=47, Suspended, 
    N=47 --> 3 | Trial completion date: Sep 2021 --> Feb 2020 | Suspended --> Terminated | Trial primary completion date: Nov 2020 --> Feb 2020; Initiated a new randomized trial per discussion with FDA Recruiting --> Suspended
  • ||||||||||  T-Guard (SPV-T3a-RTA/WT1-RTA) / Xenikos
    Trial completion, Trial primary completion date:  Safety and Efficacy Study of T-Guard to Treat Steroid-resistant Acute GVHD (clinicaltrials.gov) -  Jun 7, 2017   
    P1/2,  N=20, Completed, 
    A multicenter phase III study is planned to start in 2019 (BMT-CTN 1802). Recruiting --> Completed | Trial primary completion date: Jul 2015 --> Sep 2016