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The purpose of this study is to evaluate the pharmacokinetic of the experimental drug 304 injection compared with rituximab injection in patients with CD20 positive B-cell non-Hodgkin lymphoma who had previously achieved CR/CRu status but had not deteriorated or relapsed. While to assess the safety and efficacy of the experimental drug 304 injection compared with rituximab injection.
This is a multi-center, randomized, double-blind, parallel controlled, single-dose study to evaluate the pharmacokinetic, safety and efficacy of 304 injection compared with rituximab injection. To avoid the impact of tumor burden on pharmacokinetics, this study will be conducted in CD20 positive B-cell non-Hodgkin lymphoma patients who have achieved CR/CRu status and have not yet deteriorated or relapsed. All patients will be randomly averagely entered into the experimental group and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL |
|
| control group | Active Comparator | Rituximab will be administered single dose IV in the patients with CD20 positive B cell NHL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 304 injection | Drug | Monoclonal antibodies, 100mg/10ml per injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC [0-t] | To assess PK parameter of plasma 304 or rituximab: Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC [0-t]) | For 85 days |
| AUC [0-∞] | To assess PK parameter of plasma 304 or rituximab: Area under the concentration-time curve from time zero extrapolated to infinity (AUC [0-∞]) | For 85 days |
| Cmax | To assess PK parameter of plasma 304 or rituximab:Observed maximum plasma concentration (Cmax) | For 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| tmax | To assess PK parameter of plasma 304 or rituximab:Time to Cmax (tmax) | For 85 days |
| t1/2 | To assess PK parameter of plasma 304 or rituximab:Elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Tong | Contact | +86- 21- 84892211 | tonggang@3sbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 307 Hospital of People's Liberation Army | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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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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| rituximab injection |
| Drug |
100mg/10ml per injection ,manufactured by Roche |
|
| For 85 days |
| MRT | To assess PK parameter of plasma 304 or rituximab:Mean residence time (MRT) | For 85 days |
| Vz | To assess PK parameter of plasma 304 or rituximab:Apparent volume of distribution(Vz) | For 85 days |
| CLz | To assess PK parameter of plasma 304 or rituximab:apparent clearance (CLz) | For 85 days |
| ADA | To evaluate the incidence of anti-304 and anti-rituximab antibodies | Up to 9 months |
| Adverse events | To evaluate the adverse events (incidence, severity, outcome, causality with the investigational drug, etc.). | Up to 85 days |
| Beijing Luhe Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 101100 | China |
|
| Sun Yat-Sen University Cancer Hospital | Recruiting | Guangzhou | Guangdong | 510600 | China |
|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050010 | China |
|
| Affiliated Hospital of Hebei University | Recruiting | Baoding | Heibei | 071000 | China |
|
| Zhengzhou Central Hospital | Recruiting | Zhengzhou | Henan | 450007 | China |
|
| The First Affiliated Hospita of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| Weihai Municipal Hospital | Recruiting | Weihai | Shandong | 264200 | China |
|
| Tianjin Medical University Cancer Institute &Hospital | Recruiting | Tianjing | Tianjing | 300060 | China |
|
| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Zhejiang | 215000 | China |
|
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |