Actively Recruiting
Real-World Study of Obinutuzumab-Based Treatment for Adults with Untreated Follicular Lymphoma
Led by Ruijin Hospital · Updated on 2023-06-12
332
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of obinutuzumab-based therapy in patients with previously untreated follicular lymphoma. This observational real-world study collects data from actual clinical practice, including patient demographics, tumor details, lab tests, past treatments, side effects, treatment responses, and possible factors that affect prognosis. The study is sponsored by Ruijin Hospital. Participants receive one of three treatment regimens involving obinutuzumab given by intravenous infusion, combined with either lenalidomide, bendamustine, or a combination of prednisone, cyclophosphamide, vincristine, and doxorubicin. Treatments include an induction phase of six 21-day cycles followed by maintenance therapy with obinutuzumab every three months for two years, and lenalidomide or no additional drugs depending on the regimen. During the study, participants undergo various assessments including imaging scans to measure tumor response, lab tests, and monitoring of side effects. Researchers evaluate the objective response rate six weeks after the last induction dose, along with complete response rate, progression-free survival, and duration of response over up to two years. The study tracks patient outcomes and safety throughout the treatment and follow-up periods, which extend until mid-2027.
CONDITIONS
Brief Title
A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
Research Team
W
Weili Zhao, +862164370045
P
Pengpeng Xu, PhD,MD
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