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This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase â…¢ study.
Primary objective:
The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and rituximab plus CHOP, as first-line treatment of diffuse large B-cell lymphoma.
Secondary objective:
The purpose is to compare the safety of H02 combined with CHOP regimen and rituximab injection (Rituximab®) combined with CHOP regimen in the treatment of newly treated diffuse large B-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H02+ Chemotherapy | Experimental | Participants received six cycles of H02(375 mg/m2) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone/prednisolone(CHOP) chemotherapy(21-day cycles). |
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| Rituxan+Chemotherapy | Active Comparator | Participants received six cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H02+CHOP | Drug | Drug:H02 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug:Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(based on the evaluation of the IRC) | To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six periods of treatment. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(based on the judgment of the investigator) | 18 weeks | |
| Complete response (CR) rate (based on the evaluation of the IRC and investigator) | CR was defined as the complete disappearance of all previously detectable disease signs. CR rate was percentage of participants with a CR event. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianfeng zhou, Doctor | Contact | 13627284963 | jfzhoutj@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong New Time Pharmaceutical Co., LTD | Recruiting | Linyi | Shandong | 276006 | China |
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| Rituxan +CHOP | Drug | Drug: Rituxan 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug : Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle. |
|
| 18 weeks |
| 1-year progression-free survival (PFS) rate | PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. The proportion of subjects without disease progression or death from any cause after randomization for one year. | 1 year |
| Duration of remission within 1 year (DOR) | The time from the first assessment of complete response or partial response to the first assessment of PD or death after randomization within 1 year. | 1 year |
| 1-year overall survival (OS) rate | The proportion of subjects who did not die from any cause after randomization for 1 year. | 1 year |
| 1-year event-free survival (EFS) rate | OS was defined as the time from randomization to death from any cause. Percentage of subjects without disease progression, death, or any interruption of treatment at 1 year of randomization | 1 year |