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

• Status: Completed
• Trial end date: 2019-12-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Rituximab

Criteria

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.