:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year;
Induction treatment: Obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-4/6); for 4-6 cycles, 1 cycle = 28 days Maintenance: Obinutuzumab (G), 1000mg, IV, every 2 months for 1 year;
Prednisone (P), 100 mg, PO, D2-6;for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time frame: From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)
Objective Response rate after induction by investigator (INV)
ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV according to 2014 Lugano criteria
Time frame: From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause
Time frame: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
Progression free survival (PFS)
-PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV
Time frame: From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
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Cyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
Vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days
Doxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ,1 cycle = 28 days