Lenalidomide in patients with B-Cell Chronic Lymphocytic Leukaemia

• Research type

  Research Study

• Full title

  A Phase 3, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients with B-Cell Chronic Lymphocytic Leukaemia following Second-line Therapy. (THE CONTINUUM TRIAL)

• IRAS ID

  7765

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2007-001626-27

• Clinicaltrials.gov Identifier

  00774345

• 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, placebo controlled study looking at the efficacy and safety of Lenalidomide as maintenance therapy for patients with B-Cell CLL following second-line therapy.The purpose of the study is to determine if Lenalidomide is safe and effective as a maintenance therapy at improving further the quality of the response patients have achieved following their second-line therapy, and at prolonging the duration of their response. The study will compare the effects (good and bad) of lenalidomide 2.5mg on days 1-28 of the first 28-day cycle followed by 5mg on days 1-28 on the second 28-day cycle, versus no maintenance treatment, the current standard of care for patients. Study assessments include, Physical Examinations, Blood/Urine tests, ECG, CT-Scan, bone marrow biopsy.Patients will receive oral lenalidomide 2.5mg capsule once daily on Days 1-28 of the first 28-day cycle or matching placebo. If the 2.5mg dose is well tolerated, patients will be escalated starting at the second cycle to 5mg capsule once daily on days 1-28 of each 28-day cycle or matching placebo. Following 5 continuous cycles at the 5mg dose level, patients who are tolerating the 5mg dose level may be escalated to 10mg once daily on days 1-28 of each 28-day cycle up to disease progression.680 patients will be enrolled and randomised into 2 arms (1:1). 340 patients in the placebo arm and 340 patients in active study drug arm. Patients will continue treatment until disease progression develops.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  09/H0301/5

• Date of REC Opinion

  14 Apr 2009

• REC opinion

  Further Information Favourable Opinion