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The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma.
The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | SCT400:375 mg/m2, iv, one infusion |
|
| Active Comparator | Active Comparator | Rituximab: 375 mg/m2, iv, one infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT400 | Drug |
| ||
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) for SCT400 and rituximab concentrations | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC for SCT400 and rituximab concentrations | 1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks | |
| Maximum observed concentration of the SCT400 and rituximab | 85 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100076 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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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|
| Change from baseline of CD19+ , CD20+ B-cells |
| 85 days |
| Comparison of AEs between the two study arms | 85 days |
| Comparison of HACA between the two study arms | 85 days |
| 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 |