A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

Study Overview
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Brief Summary
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The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.

Official Title
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A Multicenter, Randomized, Double-blind, Controlled, Phase III Study to Evaluate the Efficacy and Safety of IBI301 (Recombinant Chimeric Anti-CD20 Monoclonal Antibody ) in Combination With CHOP Regimen Versus Rituximab in Combination With CHOP Regimen in Treatment-naïve Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Conditions
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Diffuse, Large B-Cell, Lymphoma

Intervention / Treatment
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* Drug: IBI301 plus CHOP
* Drug: Rituximab plus CHOP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Untreated CD20-positive DLBCL confirmed by histopathology or cytology. 18 years to 75 years; Male or female patients. International Prognostic Index (IPI) score of 0 to 2. Signed an informed consent. At least one measurable lesions: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. More than 6 months life expectancy. Exclusion Criteria: Participation in another interventional clinical trial in the past 3 months. Known allergic reactions against monoclonal antibody or rituximab. Contraindication to any component of CHOP regimen. Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month. History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis). Primary central nervous system (CNS) lymphoma, secondary CNS involvement, primary testicular lymphoma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI301<br>IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) | Drug: IBI301 plus CHOP<br>* Six cycles. IBI301: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.<br>|
| Active Comparator: Rituximab<br>Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) | Drug: Rituximab plus CHOP<br>* Six cycles. Rituximab: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate(ORR) |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission(CR) |  | 18 weeks | 
| Progression-free survival(PFS) |  | 1 year | 
| Event-free survival(EFS) |  | 1 year | 
| Overall survival(OS) |  | 1 year |