Lenalidomide vs Chlorambucil in patients with B-Cell CLL

• Research type

  Research Study

• Full title

  A Phase 3, Multicentre, Randomised, Open-Label, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients with B-Cell Chronic Lymphocytic Leukaemia. (The Origin Trial)

• IRAS ID

  19087

• Contact name

  David Oscier

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2008-003079-32

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Chronic Lymphocytic Leukaemia (CLL) is the most prevalent adult leukaemia among Caucasians. It affects mainly elderly individuals with the median age at presentation of 65-70 years, but up to one third of newly diagnosed patients are < 55 years. CLL has generally been considered incurable. Lenalidomide is an investigational drug under development by Celgene Corporation. This study is a phase 3, multi-centre, randomised, open-label, parallel group study of the efficacy and safety Lenalidomide versus Chlorambucil as first-line therapy for previously untreated elderly patients with B-Cell chronic lymphocytic leukaemia. The purpose of the study is to evaluate whether Lenalidomide will be superior to Chlorambucil at prolonging progression free survival. The study will compare the effects (good and bad) of Lenalidomide 5mg (or 2.5mg if the patient has kidney problems), everyday for 28 days followed by a monthly dose increase (15mg will be the highest dose of Lenalidomide given [7.5mg for patients with kidney problems]), versus Chlorambucil given at a dose of 0.8 mg/kg on days 1 and 15 of each 28 day cycle. Study assessments include, Physical Examinations, Blood/Urine tests, ECG, CT-Scans/Chest X-rays, bone marrow biopsy. This study will involve approximately 428 patients globally over a 4-year period.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  09/H1107/103

• Date of REC Opinion

  5 Feb 2010

• REC opinion

  Further Information Favourable Opinion