A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)

Trial Profile

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Duvelisib (Primary) ; Ofatumumab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms DUO
  • Sponsors Infinity Pharmaceuticals; Verastem
  • Most Recent Events

    • 01 Nov 2017 According to a Verastem media release, company expects to submit the duvelisib NDA for the treatment of patients with relapsed or refractory CLL/SLL during the first quarter of 2018.
    • 01 Nov 2017 According to a Verastem media release, data will be presented at the upcoming American Society of Hematology (ASH) 2017 Annual Meeting.
    • 31 Oct 2017 According to a Verastem media release, based on the written feedback from the U.S. Food and Drug Administration (FDA) regarding the regulatory path for duvelisib, the company intends to submit a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL).
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