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

Primary Purpose

Diffuse, Large B-Cell, Lymphoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

IBI301 plus CHOP

Rituximab plus CHOP

About this trial

This is an interventional treatment trial for Diffuse, Large B-Cell, Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Institute of Hematology; Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IBI301

Rituximab

Arm Description

IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Outcomes

Primary Outcome Measures

Overall response rate(ORR)

Secondary Outcome Measures

Complete remission(CR)

Progression-free survival(PFS)

Event-free survival(EFS)

Overall survival(OS)

Full Information

NCT ID

NCT02867566

First Posted

August 11, 2016

Last Updated

August 11, 2020

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02867566

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

August 22, 2016 (Actual)

Primary Completion Date

September 5, 2019 (Actual)

Study Completion Date

December 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse, Large B-Cell, Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

420 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IBI301

Arm Type

Experimental

Arm Description

IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Arm Title

Rituximab

Arm Type

Active Comparator

Arm Description

Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Intervention Type

Drug

Intervention Name(s)

IBI301 plus CHOP

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Rituximab plus CHOP

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall response rate(ORR)

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Complete remission(CR)

Time Frame

18 weeks

Title

Progression-free survival(PFS)

Time Frame

1 year

Title

Event-free survival(EFS)

Time Frame

1 year

Title

Overall survival(OS)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lugui Qiu

Organizational Affiliation

Hematology Hospital of Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Hematology; Chinese Academy of Medical Sciences

City

Tianjin

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33751401

Citation

Song Y, Zhou H, Zhang H, Liu W, Shuang Y, Zhou K, Lv F, Xu H, Zhou J, Li W, Wang H, Zhang H, Huang H, Zhang Q, Xu W, Ge Z, Xiang Y, Wang S, Gao D, Yang S, Lin J, Wang L, Zou L, Zheng M, Liu J, Shao Z, Pang Y, Xia R, Chen Z, Hou M, Yao H, Feng R, Cai Z, Zhang M, Ran W, Liu L, Zeng S, Yang W, Liu P, Liang A, Zuo X, Zou Q, Ma J, Sang W, Guo Y, Zhang W, Cao Y, Li Y, Feng J, Du X, Zhang X, Zhao H, Zhou H, Yu J, Sun X, Zhu J, Qiu L. Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial. Adv Ther. 2021 Apr;38(4):1889-1903. doi: 10.1007/s12325-020-01603-8. Epub 2021 Mar 9.

Results Reference

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

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