A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 and Ibrutinib (BIG) Followed by GA101 and Ibrutinib Maintenance in CLL Patients (CLL2-BIG Protocol)

Trial Profile

A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 and Ibrutinib (BIG) Followed by GA101 and Ibrutinib Maintenance in CLL Patients (CLL2-BIG Protocol)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 14 Nov 2017

At a glance

  • Drugs Obinutuzumab (Primary) ; Bendamustine; Ibrutinib
  • Indications Chronic lymphocytic leukaemia
  • Focus Therapeutic Use
  • Most Recent Events

    • 06 Dec 2016 Primary endpoint (Overall response rate (ORR)) has been met,according to the results published at the 58th Annual Meeting and Exposition of the American Society of Hematology.
    • 06 Dec 2016 Results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
    • 23 Dec 2015 Status changed from recruiting to active, no longer recruiting, as reported by ClinicalTrials.gov.
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