RHCACD20MA (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    


Intervention name(s): HS006+CHOP; HS006+CHOP; Rituximab+CHOP
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, single-blind, controlled, multicenter phase II study.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Previously untreated DLBCL