A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
Public ClinicalTrials.gov record NCT01414205. 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
An Open-label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.
Study identification
- NCT ID
- NCT01414205
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 80 participants
Conditions and interventions
Conditions
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
- Oct 31, 2011 (Actual)
- Primary completion
- Mar 31, 2013 (Actual)
- Completion
- Mar 31, 2016 (Actual)
- Last update posted
- Apr 17, 2017
2011 – 2016
United States locations
- U.S. sites
- 31
- U.S. states
- 15
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr | Birmingham | Alabama | 35291-3300 | — |
| Arizona Oncology | Tucson | Arizona | 85704 | — |
| Arizona Clinical Research Ctr | Tucson | Arizona | 85715 | — |
| University of California; Moores Cancer Center | La Jolla | California | 92093 | — |
| USC Norris Cancer Center | Los Angeles | California | 90033 | — |
| USC/Norris Can Ctr; IDS Pharm | Los Angeles | California | 90033 | — |
| Ventura County Hematology-Oncology Specialists | Oxnard | California | 93030 | — |
| Wilshire Oncology Medical Group | Pasadena | California | 91750 | — |
| Univ of Colorado Canc Ctr | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Center; Medical Oncology | Denver | Colorado | 80218 | — |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | — |
| Goshen Hlth Sys Ctr Can Care | Goshen | Indiana | 46526 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Horizon Oncology Research, Inc. | Lafayette | Indiana | 47905 | — |
| Purchase Cancer Group | Paducah | Kentucky | 42001 | — |
| Hem Onc Assoc of Northern NJ; Carol G. Simon Canc Ctr | Morristown | New Jersey | 07962 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Mark H. Zangmeister Center | Columbus | Ohio | 43219 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| INTEGRIS Cancer Inst of OK | Oklahoma City | Oklahoma | 73142 | — |
| Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon | 97401-8122 | — |
| Texas Oncology-Medical City Dallas | Dallas | Texas | 75230 | — |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| US Oncology Research Pharm. | Fort Worth | Texas | 76177 | — |
| Texas Cancer Center - Sherman | Sherman | Texas | 75090-0504 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| SW Virginia Hem Onc | Roanoke | Virginia | 24014 | — |
| Shenandoah Oncology Associates | Winchester | Virginia | 22601 | — |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | — |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | — |
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 NCT01414205, 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 17, 2017 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01414205 live on ClinicalTrials.gov.