OMB110911

Trial name or title	Ofatumumab + chlorambucil versus chlorambucil monotherapy in previously untreated patients with CLL (NCT00748189)
Methods	A Phase III, open‐label, randomised trial of ofatumumab added to Clb versus Clb alone in previously untreated patients with CLL Randomisation: 2 arms: ofatumumab plus Clb versus Clb
Participants	Inclusion criteria: Confirmed CLL diagnosis and active CLL requiring treatment Considered inappropriate for fludarabine‐based therapy Not been treated for CLL before Age ≥ 18 years
Interventions	Arm 1: ofatumumab + Clb Arm 2: Clb
Outcomes	Outcomes and time points from the registered protocol of the study that are considered in the review: will report: OS PFS ORR will not report: time to next treatment TRM CRR MRD AEs number of patients discontinuing the study because of drug‐related AEs
Starting date	December 2008
Contact information	US GlaxoSmithKline Clinical Trials Call Center (GSKClinicalSupportHD@gsk.com)
Notes	Estimated enrolment: 444 Estimated primary completion date: January 2013 Study status according to ClinicalTrials.gov: this study is currently recruiting participants