Lumiliximab in untreated chronic lymphocytic leukaemia (LIFT)

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Open-Label Study to Evaluate ECG Results and Pharmacokinetic Parameters for Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination with Lumiliximab Versus FCR Alone in Subjects with Previously Untreated Chronic Lymphocytic Leukemia

• IRAS ID

  12480

• Sponsor organisation

  Biogen Idec Ltd

• Eudract number

  2008-002204-25

• Clinicaltrials.gov Identifier

  NCT00801060

• Research summary

  This phase 2 study, being funded by Biogen Idec will be run in approximately 25 sites worldwide. The purpose of the study is to evaluate the safety of lumiliximab in combination with FCRfluarabine, Cyclophosphamide and Rituximab), including whether or not there are any effects on the normal electrical activity of the heart, and to discover more about the way these drugs work in the body. Patients with untreated Chronic Lymphocytic Leukaemia (CLL) will be assigned to one of 2 treatment groups. Group A will receive lumiliximab with FCR while Group B will receive FCR alone. Data suggests that the addition of lumiliximab increases the effectiveness of FCR.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/1

• Date of REC Opinion

  21 Apr 2009

• REC opinion

  Further Information Favourable Opinion