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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Highlands Oncology Group
Springdale, Arkansas, United States
The Regents of the University of California; Office of Research
Irvine, California, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Illinois Cancer Care, P.C. - Galesburg
Galesburg, Illinois, United States
Siouxland Hematology/Oncology
Sioux City, Iowa, United States
University of Kansas; Medical Center & Medical pavilion
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
MT Cancer Inst Fndtn; MT Can Spec
Missoula, Montana, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Start Date
July 6, 2011
Primary Completion Date
February 1, 2016
Completion Date
July 30, 2021
Last Updated
August 11, 2022
1,401
ACTUAL participants
Obinutuzumab
DRUG
Cyclophosphamide
DRUG
Doxorubicin
DRUG
Vincristine
DRUG
Prednisone
DRUG
Bendamustine
DRUG
Rituximab
DRUG
Lead Sponsor
Hoffmann-La Roche
Collaborators
NCT06667687
NCT05623982
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03314974