Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Public ClinicalTrials.gov record NCT01889797. 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
Phase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response. Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma. GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death induction compared to Rituximab. It is possible that GA101 may have greater efficacy than rituximab. PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in Patients Participating in GA101 (Obinutuzumab) Approximately twenty-five patients randomized to GA101 may participate in the sub-study. Electrocardiograms and blood samples will be obtained.
Study identification
- NCT ID
- NCT01889797
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 32 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
- Nov 30, 2013
- Primary completion
- Mar 31, 2016
- Completion
- Jul 31, 2016
- Last update posted
- May 4, 2017
2013 – 2016
United States locations
- U.S. sites
- 28
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | — |
| Marin Cancer Care | Greenbrae | California | 94904 | — |
| St. Joseph's/Candler Health System | Savannah | Georgia | 31405 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Siouxland Hematology Oncology Associates | Sioux City | Iowa | 51101 | — |
| Ochsner Cancer Institute | New Orleans | Louisiana | 70121 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| St. Joseph Mercy Health System | Ann Arbor | Michigan | 48106 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Metro MN CCOP | Saint Louis Park | Minnesota | 55416 | — |
| Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Aultman Hospital | Canton | Ohio | 44710 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Toledo Community Oncology Program | Toledo | Ohio | 43617 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Reading Hospital | West Reading | Pennsylvania | 19611 | — |
| Susquehanna Health Cancer Center | Williamsport | Pennsylvania | 17701 | — |
| University of Virginia | Charlottesburg | Virginia | 22908 | — |
| Charleston Area Medical Center (CAMC) | Charleston | West Virginia | 25304 | — |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | — |
| Dean Clinic | Madison | Wisconsin | 53717 | — |
| ProHealth Care, Inc. | Waukesha | Wisconsin | 53188 | — |
| Aurora Health Care | Wauwatosa | Wisconsin | 53266 | — |
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 NCT01889797, 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 May 4, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01889797 live on ClinicalTrials.gov.