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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 adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGN-CD19A | Experimental | SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-CD19A | Drug | SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg |
|
| 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 modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007) | Through 1 month post last dose | |
| Duration of response | Until disease progression or start of new anticancer treatment, an expected average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Feldman, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama / University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
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| Overall survival | Until death or study closure, an expected average of 6 months |
| Blood concentrations of SGN-CD19A and metabolites | Cycles 1, 2, and 4: predose, 30 minutes, and up to 2, 4, 8, 24, 72, 120, 168, and 336 hours post dose start; All other cycles: predose, 30 minutes, and 168 and 336 hours post dose start; and 1 month post last dose |
| Incidence of antitherapeutic antibodies | Predose in most cycles and 1 month post last dose |
| University of Alabama at Birmingham |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States |
| City of Hope National Medical Center | Duarte | California | 91010-3000 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Children's Healthcare of Atlanta / Emory University | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D015452 | Precursor B-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| 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 |
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