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A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia

Trial Profile

A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Ofatumumab (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPLEMENT 2
  • Sponsors GlaxoSmithKline; GSK; Novartis
  • Most Recent Events

    • 02 Jul 2019 Ther trial is completed at Romania (End Date: 25 Oct 2017), as per European Clinical Trials Database record.
    • 04 Dec 2018 Results evaluating 5-year follow-up of overall survival (OS) and safety profile of the drugs presented at the 60th Annual Meeting and Exposition of the American Society of Hematology.
    • 13 Dec 2017 Status changed from active, no longer recruiting to completed.
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