Spots Global Cancer Trial Database for BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
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Trial Identification
Brief Title: BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
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
Study ID: NCT02417129
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Boehringer Ingelheim Investigational Site, Muscle Shoals, Alabama, United States
Boehringer Ingelheim Investigational Site, Bakersfield, California, United States
Boehringer Ingelheim Investigational Site, Burbank, California, United States
Boehringer Ingelheim Investigational Site, Loma Linda, California, United States
Boehringer Ingelheim Investigational Site, Albany, Georgia, United States
Boehringer Ingelheim Investigational Site, Northbrook, Illinois, United States
Boehringer Ingelheim Investigational Site, Pittsfield, Massachusetts, United States
Boehringer Ingelheim Investigational Site, Morristown, New Jersey, United States
Boehringer Ingelheim Investigational Site, East Setauket, New York, United States
Boehringer Ingelheim Investigational Site, Fayetteville, North Carolina, United States
Boehringer Ingelheim Investigational Site, Middletown, Ohio, United States
Boehringer Ingelheim Investigational Site, Corpus Christi, Texas, United States
Boehringer Ingelheim Investigational Site, Ogden, Utah, United States
Boehringer Ingelheim Investigational Site, Graz, , Austria
Boehringer Ingelheim Investigational Site, Leuven, , Belgium
Boehringer Ingelheim Investigational Site, Namur, , Belgium
Boehringer Ingelheim Investigational Site, Plovdiv, , Bulgaria
Boehringer Ingelheim Investigational Site, Sofia, , Bulgaria
Boehringer Ingelheim Investigational Site, Zagreb, , Croatia
Boehringer Ingelheim Investigational Site, Brno, , Czech Republic
Boehringer Ingelheim Investigational Site, Praha, , Czech Republic
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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