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This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | lintuzumab and lenalidomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lintuzumab | Drug | 4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events and lab abnormalities | 1 month after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor activity | Every other 21-day cycle | |
| Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA) | 1 month after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sievers, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Rocky Mountain Cancer Center |
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|
| lenalidomide | Drug | 10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle |
|
|
| Denver |
| Colorado |
| 80218 |
| United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Georgia Cancer Specialists | Atlanta | Georgia | 30342 | 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 |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D006402 | Hematologic Diseases |
| D011289 | Preleukemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C477390 | lintuzumab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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