BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Public ClinicalTrials.gov record NCT02417129. 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 III, Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate Efficacy and Safety of BI 695500 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.
Study identification
- NCT ID
- NCT02417129
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- 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
- Mar 31, 2015
- Primary completion
- Nov 30, 2015
- Completion
- Nov 30, 2015
- Last update posted
- Jan 29, 2017
2015
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Muscle Shoals | Alabama | — | — |
| Boehringer Ingelheim Investigational Site | Bakersfield | California | — | — |
| Boehringer Ingelheim Investigational Site | Burbank | California | — | — |
| Boehringer Ingelheim Investigational Site | Loma Linda | California | — | — |
| Boehringer Ingelheim Investigational Site | Albany | Georgia | — | — |
| Boehringer Ingelheim Investigational Site | Northbrook | Illinois | — | — |
| Boehringer Ingelheim Investigational Site | Pittsfield | Massachusetts | — | — |
| Boehringer Ingelheim Investigational Site | Morristown | New Jersey | — | — |
| Boehringer Ingelheim Investigational Site | East Setauket | New York | — | — |
| Boehringer Ingelheim Investigational Site | Fayetteville | North Carolina | — | — |
| Boehringer Ingelheim Investigational Site | Middletown | Ohio | — | — |
| Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | — | — |
| Boehringer Ingelheim Investigational Site | Ogden | Utah | — | — |
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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02417129, 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 Jan 29, 2017 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02417129 live on ClinicalTrials.gov.