A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML

Trial Profile

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML

Recruiting
Phase of Trial: Phase II

Latest Information Update: 02 Nov 2013

At a glance

  • Drugs Lenalidomide (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Biomarker; Therapeutic Use
  • Acronyms HOVON-103-AML-Lenalidomide
  • Most Recent Events

    • 03 Mar 2012 Planned number of patients changed from 200 to 240 as reported by European Clinical Trials Database.
    • 03 Mar 2012 Planned end date changed from 15 Sep 2012 to 13 Oct 2012 as reported by European Clinical Trials Database.
    • 24 Aug 2010 Status changed from planning to recruiting as reported by Netherlands Trial Register.
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