Lymphocytic Leukemia, Chronic Clinical Trial
Official title:
An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on
clinicaltrials.gov because there are 3 separate primary analyses conducted at different
time-points.
- BO21004 (Stage 1a) [NCT01010061] includes the analysis of 2 of the 3 arms obinutuzumab
plus chlorambucil (Glb) compared to chlorambucil (Clb) reported here.
- BO21004 (Stage 1b) [NCT01998880] includes the analysis of 2 of the 3 arms rituximab plus
chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
- BO21004 (Stage 2) [NCT02053610] includes the analysis of 2 of the 3 arms obinutuzumab
plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported
separately.
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