Diffuse, Large B-Cell, LymphomaPhase 3NCT02867566
A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
A Phase 3 study testing IBI301 plus CHOP and Rituximab plus CHOP in people with Diffuse, Large B-Cell, Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse, Large B-Cell, Lymphoma
- What is being tested?
- IBI301 plus CHOP and Rituximab plus CHOP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2016to 26 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology; Chinese Academy of Medical Sciences
Tianjin
About this study
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)
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.
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Being tested
- IBI301 plus CHOP, Rituximab plus CHOP
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI301 plus CHOPDrug
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 CHOPDrug
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 group | Role | What they receive |
|---|---|---|
| IBI301 | Experimental | IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) Receives: Drug: IBI301 plus CHOP |
| Rituximab | Active comparator | Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) Receives: Drug: Rituximab plus CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate(ORR)
Measured: 18 weeks
Secondary outcomes (4)
Complete remission(CR)
Measured: 18 weeks
Progression-free survival(PFS)
Measured: 1 year
Event-free survival(EFS)
Measured: 1 year
Overall survival(OS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start22 Aug 2016
- Primary completion5 Sep 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse, Large B-Cell, LymphomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867566
- Sponsor's protocol ID
- CIBI301A301
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33751401
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02867566
- Acronym / sponsor ID
- CIBI301A301
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI301 | Experimental | Drug: IBI301 plus CHOPIBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) |
| Rituximab | Active comparator | Drug: Rituximab plus CHOPRituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI301 plus CHOPSix 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. | Drug | IBI301 |
| Rituximab plus CHOPSix 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. | Drug | Rituximab |
Primary outcome
Overall response rate(ORR)
Time frame: 18 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 33751401Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lugui Qiu principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBI301 plus CHOP and Rituximab plus CHOP in people with Diffuse, Large B-Cell, Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate(ORR) (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.