Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

Trial Profile

Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Copanlisib (Primary)
  • Indications Anaplastic large cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; MALT lymphoma; Mantle-cell lymphoma; Non-Hodgkin's lymphoma; Peripheral T-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CHRONOS-1
  • Sponsors Bayer
  • Most Recent Events

    • 04 Oct 2017 Results assessing the efficacy and safety of copanlisib in patients with relapsed or refractory indolent B-cell lymphoma, published in the Journal of Clinical Oncology.
    • 14 Sep 2017 According to a Bayer media release, the FDA has granted approval based on data from 104 adult patients with follicular B-cell non-Hodgkin's lymphoma (NHL) who had relapsed disease following at least two prior systemic therapies.
    • 14 Sep 2017 According to a Bayer media release, based on the result of this trial FDA has approved accelerated approval for copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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