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

Phase 3

Completed

• Conditions: Diffuse, Large B-Cell, Lymphoma
• Interventions: Drug: Rituximab plus CHOP; Drug: IBI301 plus CHOP

• Registration Number: NCT02867566
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Study Start: 2016-08-22
• Primary Completion: 2019-09-05
• Study Completion: 2019-12-26
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab plus CHOP	Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
IBI301	IBI301 plus CHOP	IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Primary Outcome Measures

Name	Time	Method
Overall response rate(ORR)	18 weeks

Secondary Outcome Measures

Name	Time	Method
Complete remission(CR)	18 weeks
Event-free survival(EFS)	1 year
Overall survival(OS)	1 year
Progression-free survival(PFS)	1 year

Trial Locations

Locations (1)

Institute of Hematology; Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China