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| ID | Type | Description | Link |
|---|---|---|---|
| 1210009882 | Other Identifier | Indiana University Institutional Review Board |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab combined with SB-485232 | Experimental | Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab combined with SB-485232 | Drug | Ofatumumab with escalating doses of SB-485232 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab | Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the biologic effects of SB-485232 given in combination with ofatumumab | Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Robertson, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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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 |
|---|---|
| D020382 | Interleukin-18 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |