Trials / Completed
CompletedNCT01414855
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | obinutuzumab | 1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15. |
| DRUG | cyclophosphamide | 750 mg/m\^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles. |
| DRUG | doxorubicin | 50 mg/m\^2 IV, Day 1 of each 21-cycle, 6 cycles. |
| DRUG | prednisone | 100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles. |
| DRUG | vincristine | 1.4 mg/m\^2 IV, Day 1 of each 21-day cycle, 6 cycles. |
Timeline
- Start date
- 2011-08-31
- Primary completion
- 2013-12-31
- Completion
- 2016-12-23
- First posted
- 2011-08-11
- Last updated
- 2018-04-25
- Results posted
- 2015-03-19
Locations
38 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01414855. Inclusion in this directory is not an endorsement.