A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
• Treatment naive
• Age ≥ 18 years
• Indications for treatment confirmed
• Must has measurable lesion in CT or PET-CT prior to treatment
• Considered suitable for GR, GB or GCHOP regimens
• Informed consented
Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Weili Zhao, +862164370045
zwl_trial@163.com
+862164370045
Backup
Pengpeng Xu, PhD，MD
+862164370045
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 332
Treatments
GR
Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); lenalidomide (R), 25mg, PO, D2-11; Maintenance: obinutuzumab (G), 1000mg, every 3 months for 2 years; lenalidomide (R), 25mg, PO, D1-10, every 28 days for 6 cycles
GB
Induction(six 21-day cycles): obinutuzumab (G) 1000mg, IV, D1/8/15 (C1), D1 (C2-6); bendamustine (B), 90 mg/m2, IV, D1-2; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years
GCHOP
Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); prednisone (P), 100 mg, PO, D1-5；cyclophosphamide (C), 750 mg/m2, IV, D1; vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D1; doxorubicin (H), 50 mg/m2, IV, D1; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital