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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-40 | Drug | 1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. | Every 1 or 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, disease-free survival, and overall survival. | Study duration | |
| Adverse events, laboratory values, and anti-drug antibody immune responses. | Within 3 weeks of final infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Whiting, PharmD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic-Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24919462 | Result | de Vos S, Forero-Torres A, Ansell SM, Kahl B, Cheson BD, Bartlett NL, Furman RR, Winter JN, Kaplan H, Timmerman J, Whiting NC, Drachman JG, Advani R. A phase II study of dacetuzumab (SGN-40) in patients with relapsed diffuse large B-cell lymphoma (DLBCL) and correlative analyses of patient-specific factors. J Hematol Oncol. 2014 Jun 12;7:44. doi: 10.1186/1756-8722-7-44. |
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| PK profile. | Within 3 weeks of final infusion |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| Sharp Healthcare | San Diego | California | 92123 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Mayo Clinic-Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29403 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D006402 | Hematologic Diseases |
| D007160 | Immunoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C543331 | dacetuzumab |
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