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This is a randomised, double-blind, positive drug parallel controlled equivalence clinical trial initiated at about 30 sites in China.
In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIBP-02 | Experimental | Biological: SIBP-02, 375 mg/m2, intravenous infusion, administered on day1. Drug: Cyclophosphamide, 750 mg/m2, intravenous infusion, administered on day2. Drug: Doxorubicin Hydrochloride, 50 mg/m2, intravenous infusion, administered on day2. Drug: Vincristine Sulfate, 1.4 mg/m2, intravenous infusion, administered on day2. Drug: Prednisone Acetate Tablets, 100 mg, orally administered on day2-6, one time per day. Treatment cycle: 6 cycles, each cycle is 3 weeks. |
|
| Rituximab | Active Comparator | Biological: Rituximab, 375 mg/m2, intravenous infusion, administered on day1. Drug: Cyclophosphamide, 750 mg/m2, intravenous infusion, administered on day2. Drug: Doxorubicin Hydrochloride, 50 mg/m2, intravenous infusion, administered on day2. Drug: Vincristine Sulfate, 1.4 mg/m2, intravenous infusion, administered on day2. Drug: Prednisone Acetate Tablets, 100 mg, orally administered on day2-6, one time per day. Treatment cycle: 6 cycles, each cycle is 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIBP-02 | Drug | Injection,100mg/10ml |
| |
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | defined as the proportion of patients with Complete Response (CR) and Partial Response (PR) in accordance with the evaluation criteria of the International Working Group (IWG) Lymphoma Efficacy Evaluation System (2007) | After 6 cycles of treatment, each cycle is 3 weeks |
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Inclusion Criteria:
White blood cell count (WBC) ≥ 4.0 × 109/L or the lower limit of normal of the local laboratory; patients with bone marrow invasion, WBC ≥ 3.0 × 109/L; Absolute neutrophil count (ANC) ≥ 2.0 × 109/L or the lower limit of normal of the local laboratory; in the patients with bone marrow invasion, ANC ≥ 1.5 × 109/L; Hemoglobin (HB) ≥ 90 g/L; in the patients with bone marrow invasion, HB ≥ 80 g/L; Platelets (PLT) ≥ 100 × 109/L; in the patients with bone marrow invasion, PLT ≥ 75 × 109/L; Total bilirubin ≤ 1.5 times upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase ≤ 1.5 × ULN in the patients without bone marrow invasion; Serum creatinine level ≤ 1.5 × ULN;
Exclusion Criteria:
Chemotherapy and immunotherapy; Radiotherapy or local radiotherapy for DLBCL; Monoclonal antibody therapy (including Rituxan® and biosimilars of Rituxan®) Surgery (except biopsy);
Cardiovascular disease: congestive heart failure (NYHA Class III-IV), unstable angina, poorly controlled arrhythmias, poorly controlled hypertension or hypotension or myocardial infarction in the past 6 months; Severe mental illness; Gastric ulcer, intestinal infarction or gastrointestinal perforation (except for ones caused by primary disease); Pulmonary diseases (asthma, interstitial lung disease or severe obstructive pulmonary disease); Poorly controlled diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Shanghai Institute Of Biological Products Co., Ltd | SINOPHARM | Study Director |
| The First Affiliated Hospital of College of Medicine | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Injection,100mg/10ml |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |