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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02867566

Enrollment

420

Registered

2016-08-16

Start date

2016-08-22

Completion date

2019-12-26

Last updated

2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse, Large B-Cell, Lymphoma

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.

Interventions

DRUGIBI301 plus CHOP

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.

DRUGRituximab plus CHOP

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Overall response rate(ORR)	18 weeks

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026