This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Induction therapy: The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles. Dosage: 1. Zanubrutinib, 160 mg bid, po, day 1-28; 2. Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6); 3. Lenalidomide, 25 mg qd, po, day 2-11. Maintenance therapy: 1. Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years; 2. Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Objective response rate (ORR)
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Complete response rate (CR)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Partial response rate (PR)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Duration of response
Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2-year progression free survival rate
progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2-year overall survival rate
progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of death from any cause.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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