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An open-labeled, randomized, two-dose, parallel group trial of ofatumumab, a fully human monoclonal anti-CD20 antibody, in combination with fludarabine and cyclophosphamide, in patients with previously untreated B-cell Chronic Lymphocytic Leukemia.

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Trial Profile

An open-labeled, randomized, two-dose, parallel group trial of ofatumumab, a fully human monoclonal anti-CD20 antibody, in combination with fludarabine and cyclophosphamide, in patients with previously untreated B-cell Chronic Lymphocytic Leukemia.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Ofatumumab (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Chronic lymphocytic leukaemia
  • Focus Therapeutic Use
  • Acronyms BIFROST
  • Sponsors Genmab; GlaxoSmithKline; GSK

Most Recent Events

  • 06 May 2012 Official Title amended as reported by European Clinical Trials Database record.
  • 13 Dec 2011 Relationship between pharmacokinetics and response results presented at the 53rd Annual Meeting and Exposition of the American Society of Hematology.
  • 16 Jun 2011 Planned End Date changed from 1 Sep 2013 to 1 Jun 2013 as reported by ClinicalTrials.gov.

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