RHCACD20MA (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.
Study ID
NCT03485118
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HS006+CHOP — DRUG
    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.
  • HS006+CHOP — DRUG
    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.
  • Rituximab+CHOP — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 12, 2016
Status verified
Mar 2018
Primary completion
Aug 12, 2016
Completion
Jan 14, 2018

Study Design

Enrollment
137 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HS006+Chemotherapy
    1. Participants received six 21-day cycles of HS006(375 mg per square meter) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone/prednisolone(CHOP) chemotherapy(21-day cycles). 2. Participants received six 21-day cycles of HS006(500 mg per square meter) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles).
  • Active Comparator: Rituxan+Chemotherapy
    Participants received six 21-day cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles).

Primary Outcome Measure

ORR [ Time Frame: 18 weeks ]

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