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Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lintuzumab | Drug | 1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events and lab abnormalities. | 13 months | |
| Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA). | 13 months | |
| Antitumor activity. | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sievers, M.D. | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States | ||
| Cancer Care Specialists of Central Illinois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19557623 | Result | Raza A, Jurcic JG, Roboz GJ, Maris M, Stephenson JJ, Wood BL, Feldman EJ, Galili N, Grove LE, Drachman JG, Sievers EL. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzumab: a phase 1 trial. Leuk Lymphoma. 2009 Aug;50(8):1336-44. doi: 10.1080/10428190903050013. |
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|
| Decatur |
| Illinois |
| 62526 |
| United States |
| Indiana Oncology-Hematology Consultants | Indianapolis | Indiana | 46107 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01605 | United States |
| St. Vincent's Comprehensive Cancer Center | New York | New York | 10011 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Cancer Center of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D006402 | Hematologic Diseases |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C477390 | lintuzumab |
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