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This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGN-CD19A | Experimental | SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-CD19A | Drug | SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Through 1 month post last dose | |
| Incidence of laboratory abnormalities | Through 1 month post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response according to revised response criteria for malignant lymphoma (Cheson 2007) | Through up to approximately 6 week post last dose | |
| Duration of response | Until disease progression or start of new anticancer treatment, an expected average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Kostic, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| City of Hope National Medical Center |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D015452 | Precursor B-Cell Lymphoblastic Leukemia-Lymphoma |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| Overall survival | Until death or study closure, an expected average of 1 year |
| Blood concentration of SGN-CD19A and metabolites | Through up to approximately 6 weeks post last dose |
| Incidence of antitherapeutic antibodies | Through up to approximately 6 weeks post last dose |
| Duarte |
| California |
| 91010-3000 |
| United States |
| Stanford Cancer Center | Stanford | California | 94305 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | United States |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |