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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ClinicalTrials.gov Identifier: NCT02867566 |
Recruitment Status :
Completed
First Posted : August 16, 2016
Last Update Posted : August 12, 2020
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Condition or disease | Intervention/treatment | Phase |
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Diffuse, Large B-Cell, Lymphoma | Drug: IBI301 plus CHOP Drug: Rituximab plus CHOP | Phase 3 |
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 |

Arm | Intervention/treatment |
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Experimental: IBI301
IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
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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)
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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. |
- Overall response rate(ORR) [ Time Frame: 18 weeks ]
- Complete remission(CR) [ Time Frame: 18 weeks ]
- Progression-free survival(PFS) [ Time Frame: 1 year ]
- Event-free survival(EFS) [ Time Frame: 1 year ]
- Overall survival(OS) [ Time Frame: 1 year ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867566
China | |
Institute of Hematology; Chinese Academy of Medical Sciences | |
Tianjin, China |
Principal Investigator: | Lugui Qiu | Hematology Hospital of Chinese Academy of Medical Sciences |
Responsible Party: | Innovent Biologics (Suzhou) Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT02867566 |
Other Study ID Numbers: |
CIBI301A301 |
First Posted: | August 16, 2016 Key Record Dates |
Last Update Posted: | August 12, 2020 |
Last Verified: | August 2016 |
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 |