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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP2013 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP2013 | Drug | GP2013 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety of GP2013 | Adverse events, laboratory abnormalities | 12 weeks |
| Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013 | 12 weeks | |
| Maximum observed concentration of GP2013 | 12 weeks | |
| Time to reach maximum concentration of GP2013 | 12 weeks | |
| Minimum (trough) observed concentration during each dosing interval of GP2013 | 12 weeks | |
| Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013 | 12 weeks | |
| Elimination half-life associated with the terminal slope of GP2013 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate efficacy of GP2013 | Antitumor activity | 12 weeks |
| To evaluate the incidence of immunogenicity (ADA formation) against GP2013 | Immunogenicity (ADA formation) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz K.K. | Sandoz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Tachikawa | Tokyo | 190-0014 | Japan |
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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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| 12 weeks |
| To evaluate peripheral CD19+ B-cell count | CD19 + B-cell count | 12 weeks |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |