GSKStudy ID 110913

Trial name or title	Ofatumumab added to FC versus FC in relapsed subjects with CLL (NCT00824265)
Methods	A Phase III, open‐labee, randomised trial of ofatumumab added to FluC versus FluC alone in subjects with relapsed CLL Randomisation: 2 arms: FCO versus FluC
Participants	Inclusion criteria: confirmed and active CLL requiring treatment at least 1 previous treatment for CLL and having achieved a complete or partial remission/response but after a period of ≥ 6 months, shows evidence of disease progression Age ≥ 18 years
Interventions	Arm 1: FCO Arm 2: FluC
Outcomes	Outcomes and time points from the registered protocol of the study that are considered in the review: will report: PFS will not report: OS time to next treatment TRM CRR ORR MRD AEs number of patients discontinuing the study because of drug‐related AEs
Starting date	March 2009
Contact information	GSK Clinical Trials GlaxoSmithKline
Notes	Estimated enrolment: 352 Estimated primary completion date: December 2012 Study status according to ClinicalTrials.gov: this study is currently recruiting participants