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: 09 Apr 2018

At a glance

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

    • 09 Apr 2018 The U.S. Food and Drug Administration (FDA) has accepted New Drug Application for duvelisib and granted priority review. Application seeks full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and accelerated approval in relapsed/refractory follicular lymphoma, according to Verastem media release. The NDA is supported by clinical data from the DUO and DYNAMO studies.
    • 07 Feb 2018 According to a Verastem media release, the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking full approval for its lead product candidate duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The NDA is supported by clinical data from the DUO and DYNAMO studies.
    • 10 Dec 2017 Results published in the Verastem media release.
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