A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
NCT ID: NCT02867566
Last Updated: 2020-08-12
Study Results
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Basic Information
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COMPLETED
PHASE3
420 participants
INTERVENTIONAL
2016-08-22
2019-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IBI301
IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
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.
Rituximab
Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lugui Qiu
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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Institute of Hematology; Chinese Academy of Medical Sciences
Tianjin, , China
Countries
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References
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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.
Other Identifiers
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CIBI301A301
Identifier Type: -
Identifier Source: org_study_id
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