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
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