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

• ClinicalTrials.gov Identifier: NCT02867566
• Recruitment Status: Completed
• First Posted: August 16, 2016
• Last Update Posted: August 12, 2020
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Information provided by (Responsible Party): Innovent Biologics (Suzhou) Co. Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Diffuse, Large B-Cell, Lymphoma	Drug: IBI301 plus CHOP; Drug: Rituximab plus CHOP	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: August 22, 2016
• Actual Primary Completion Date: September 5, 2019
• Actual Study Completion Date: December 26, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: IBI301; IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)	Drug: IBI301 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.
Active Comparator: Rituximab; Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)	Drug: Rituximab 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.

Outcome Measures

Primary Outcome Measures :

1. Overall response rate(ORR) [ Time Frame: 18 weeks ]

Secondary Outcome Measures :

1. Complete remission(CR) [ Time Frame: 18 weeks ]
2. Progression-free survival(PFS) [ Time Frame: 1 year ]
3. Event-free survival(EFS) [ Time Frame: 1 year ]
4. Overall survival(OS) [ Time Frame: 1 year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China

Institute of Hematology; Chinese Academy of Medical Sciences

Tianjin, China

Sponsors and Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

• Principal Investigator: Lugui Qiu; Hematology Hospital of Chinese Academy of Medical Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT02867566
• Other Study ID Numbers: CIBI301A301
• First Posted: August 16, 2016
• Last Update Posted: August 12, 2020
• Last Verified: August 2016

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Rituximab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents