A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Public ClinicalTrials.gov record NCT01414855. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01414855
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- obinutuzumab Drug
- cyclophosphamide Drug
- doxorubicin Drug
- prednisone Drug
- vincristine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 30, 2011
- Primary completion
- Dec 30, 2013
- Completion
- Dec 22, 2016
- Last update posted
- Apr 24, 2018
2011 – 2016
United States locations
- U.S. sites
- 38
- U.S. states
- 25
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | — |
| cCare | Encinitas | California | 92024 | — |
| University of Colorado Cancer Center Department of Hematology | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Ctr - Denver (Williams) | Denver | Colorado | 80218 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Florida Cancer Specialists; Department of Oncology | Fort Myers | Florida | 33901-8101 | — |
| Florida Cancer Specialists; Saint Petersburg | St. Petersburg | Florida | 33719 | — |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | — |
| Kootenai Medical Center | Coeur d'Alene | Idaho | 83814 | — |
| Northwestern University; Robert H. Lurie Comp Can Ctr | Chicago | Illinois | 60611 | — |
| Onc Hem Assoc of Central IL | Peoria | Illinois | 61615-7828 | — |
| McFarland Clinic | Ames | Iowa | 50010 | — |
| Jewish Cancer Care | Louisville | Kentucky | 40245 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | — |
| MT Cancer Inst Fndtn; MT Can Spec | Missoula | Montana | 59802 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | — |
| MSKCC at Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| Memorial Sloan-Kettering; Cancer Center | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| MSKCC at Mercy Med Ctr | Rockville Centre | New York | 11570 | — |
| MSKCC at Sleepy Hollow | Sleepy Hollow | New York | 10591 | — |
| Emerywood Hematology and Onc | High Point | North Carolina | 27262 | — |
| Willamette Valley Cancer Insitute and Research Center | Springfield | Oregon | 97477 | — |
| Medical University of SC (MUSC) | Charleston | South Carolina | 29425 | — |
| SCRI-Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Onc & Hem Assoc; USO Cent Pharm | Fort Worth | Texas | 76177 | — |
| MD Anderson Cancer Center Department of Lymphoma & Myeloma | Houston | Texas | 77030 | — |
| Methodist Hospital Research Institute | Houston | Texas | 77030 | — |
| Cancer Therapy & Research Center | San Antonio | Texas | 78229 | — |
| USO - Tyler Cancer Ctr | Tyler | Texas | 75702 | — |
| Blue Ridge Cancer Care - Roanoke | Roanoke | Virginia | 24014 | — |
| Medical Oncology Associates | Spokane | Washington | 99208 | — |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | — |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | — |
| Aurora Bay Care Medical Center | Green Bay | Wisconsin | 54311 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01414855, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 24, 2018 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01414855 live on ClinicalTrials.gov.