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This Phase II, single-arm, open-label, multicenter trial is designed to evaluate the safety, efficacy, and pharmacokinetics of PRO95780 when combined with rituximab in patients with follicular, CD20-positive B-cell NHL that has progressed following previous rituximab therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO95780 | Drug | Intravenous repeating dose |
| |
| rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response, as determined by independent review facility | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, as determined by independent review facility | up to 12 months | |
| Duration of objective response, as determined by independent review facility | up to 10.3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Bray, M.D. | Genentech, Inc. | Study Director |
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| Drug |
Intravenous repeating dose |
|
| Overall survival |
| Up to 18.5 months |
| Objective response, as determined by the investigator | Up to 8 months |
| Progression-free survival, as determined by the investigator | Up to 18.5 months |
| Duration of objective response, as determined by the investigator | Up to 14.1 months |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C548876 | drozitumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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