A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Public ClinicalTrials.gov record NCT01332968. 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 Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response \[CR\] or partial response \[PR\]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Study identification
- NCT ID
- NCT01332968
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,401 participants
Conditions and interventions
Conditions
Interventions
- Obinutuzumab Drug
- Cyclophosphamide Drug
- Doxorubicin Drug
- Vincristine Drug
- Prednisone Drug
- Bendamustine Drug
- Rituximab 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
- Jul 6, 2011 (Actual)
- Primary completion
- Feb 1, 2016 (Actual)
- Completion
- Jul 30, 2021 (Actual)
- Last update posted
- Aug 11, 2022
2011 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | — |
| The Regents of the University of California; Office of Research | Irvine | California | 92697 | — |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | — |
| Illinois Cancer Care, P.C. - Galesburg | Galesburg | Illinois | 61401 | — |
| Siouxland Hematology/Oncology | Sioux City | Iowa | 51101 | — |
| University of Kansas; Medical Center & Medical pavilion | Westwood | Kansas | 66205 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | — |
| Mercy Medical Research Institute | Springfield | Missouri | 65807 | — |
| MT Cancer Inst Fndtn; MT Can Spec | Missoula | Montana | 59802 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 171 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01332968, 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 Aug 11, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01332968 live on ClinicalTrials.gov.