Open-Label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-Cell CLL.

Trial Profile

Open-Label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-Cell CLL.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Rituximab (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms REACH
  • Sponsors Roche
  • Most Recent Events

    • 01 Apr 2010 Results published in JCO.
    • 19 Feb 2010 Based on results of this trial and the CLL8 study, Rituxan + fludarabine + cyclophosphamide has been approved by the US FDA for patients with previously untreated or treated CLL, according to a Genentech/Biogen Idec media release.
    • 05 Dec 2009 Pharmacokinetic substudy results presented at the 51st Annual Meeting and Exposition of the American Society of Hematology.
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