Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lintuzumab plus low dose cytarabine |
|
| 2 | Active Comparator | Placebo plus low dose cytarabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lintuzumab (SGN-33) | Drug | 600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics | 13 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Sievers, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center | Mobile | Alabama | 36608 | United States | ||
| Tower Cancer Research Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22801961 | Result | Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low dose cytarabine | Drug | 20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles. |
|
|
| Placebo | Drug | IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles |
|
| Beverly Hills |
| California |
| 90210 |
| United States |
| Glendale Memorial Hospital | Glendale | California | 91204 | United States |
| Kenmar Research Institute | Los Angeles | California | 90057 | United States |
| University of California Los Angeles | Los Angeles | California | 90095-1678 | United States |
| Bay Area Cancer Research Group | Pleasant Hill | California | 94523 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Joliet Oncology-Hematology Associates | Joliet | Illinois | 60435 | United States |
| Michigan State University, Breslin Cancer Center | Lansing | Michigan | 48910 | United States |
| Billings Clinic Cancer Research | Billings | Montana | 59101 | United States |
| Northshore University Hospital, Monter Cancer Center | Lake Success | New York | 11042 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| Cancer Centers of the Carolinas | Greenville | South Carolina | 29601 | United States |
| University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Gunderson Clinic | La Crosse | Wisconsin | 54601 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D006402 | Hematologic Diseases |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C477390 | lintuzumab |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided