Primary objective: To evaluate the efficacy of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) versus Rituximab with CHOP (R-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma as first line treatment. Secondary objective: To evaluate the safety of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma. To study the pharmacokinetics of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) in patients with previously untreated Diffuse Large B-cell Lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
137
Drug:HS006 HS006 375 mg per square meter (mg/m\^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
Drug:HS006 HS006 500 mg per square meter (mg/m\^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. During cycle 1,HS006 also infused on Day 8 and 15. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 1-5 of each 21-day cycle.
Drug:Rituxan Rituxan 375 mg per square metre (mg/m\^2), administered by intravenous (IV) on Day 1 of each 21-day cycle. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
ORR
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
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