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

Innovent Biologics

Status and phase

Completed

Phase 3

Conditions

Diffuse, Large B-Cell, Lymphoma

Treatments

Drug: IBI301 plus CHOP

Drug: Rituximab plus CHOP

Study type

Interventional

Funder types

Industry

Identifiers

NCT02867566

CIBI301A301

Details and patient eligibility

About

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.

Enrollment

420 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.