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| Name | Class |
|---|---|
| Seagen Inc. | INDUSTRY |
This is an open-label, multicenter Phase Ib study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of SGN-40 when combined with rituximab in patients with relapsed CD20-positive, follicular or marginal zone NHL who have received at least one prior rituximab-containing regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Drug | Escalating intravenous repeating dose |
| |
| SGN-40 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of dose-limiting toxicities in order to determine the maximum tolerated dose | Length of study |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vital signs, physical examination findings, and clinical laboratory results | Length of study | |
| Incidence, nature, and severity of adverse events | Length of study | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Hurst, M.D. | Genentech, Inc. | Study Director |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C543331 | dacetuzumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Escalating intravenous repeating dose |
|
| Pharmacokinetic parameters |
| Length of study |
| Patient's best response as assessed by the investigator | Length of study |
| Duration of response | Length of study |
| Event-free survival | Length of study |
| 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 |