This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase Ⅲ study. Primary objective: The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and rituximab plus CHOP, as first-line treatment of diffuse large B-cell lymphoma. Secondary objective: The purpose is to compare the safety of H02 combined with CHOP regimen and rituximab injection (Rituximab®) combined with CHOP regimen in the treatment of newly treated diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
416
Drug:H02 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug:Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
Drug: Rituxan 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug : Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
Shandong New Time Pharmaceutical Co., LTD
Linyi, Shandong, China
RECRUITINGORR(based on the evaluation of the IRC)
To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six periods of treatment.
Time frame: 18 weeks
ORR(based on the judgment of the investigator)
Time frame: 18 weeks
Complete response (CR) rate (based on the evaluation of the IRC and investigator)
CR was defined as the complete disappearance of all previously detectable disease signs. CR rate was percentage of participants with a CR event.
Time frame: 18 weeks
1-year progression-free survival (PFS) rate
PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. The proportion of subjects without disease progression or death from any cause after randomization for one year.
Time frame: 1 year
Duration of remission within 1 year (DOR)
The time from the first assessment of complete response or partial response to the first assessment of PD or death after randomization within 1 year.
Time frame: 1 year
1-year overall survival (OS) rate
The proportion of subjects who did not die from any cause after randomization for 1 year.
Time frame: 1 year
1-year event-free survival (EFS) rate
OS was defined as the time from randomization to death from any cause. Percentage of subjects without disease progression, death, or any interruption of treatment at 1 year of randomization
Time frame: 1 year
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