GAO4768g

Trial name or title	A study comparing RO5072759 (GA101) 1000 mg versus 2000 mg in patients with previously untreated chronic lymphocytic leukaemia (NCT01414205)
Methods	An open‐label, randomised Phase II trial comparing the efficacy, safety and pharmacokinetics of GA101 1000 mg versus 2000 mg in patients with previously untreated CLL Randomisation: 2 arms: RO5072759 1000 mg versus RO5072759 2000 mg
Participants	Inclusion criteria: CD20‐positive B‐CLL (per IWCLL guidelines) Rai stage III/IV or Binet stage C disease, or Rai stage I/II or Binet stage B disease that requires treatment according to IWCLL guidelines No previous treatment for CLL chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for AIHA or ITP; prior use of steroids for AIHA or ITP is allowed ECOG performance status of 0, 1 or 2
Interventions	Arm 1: RO5072759 1000 mg IV dose Arm 2: RO5072759 2000 mg IV dose
Outcomes	Outcomes and time points from the registered protocol of the study that are considered in the review: will report: OS PFS ORR CRR time to next treatment will not report: MRD AEs TRM number of patients discontinuing the study because of drug‐related AEs
Starting date	September 2011
Contact information	Contact: Genentech Trial Information Support Line (global.rochegenentechtrials@roche.com)
Notes	Estimated enrolment: 80 Estimated primary completion date: January 2017 Study status according to ClinicalTrials.gov: this study is not yet open for participant recruitment