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Also known as Lintuzumab (SGN-33), SGN-33
lintuzumab · 3 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Lintuzumab plus low dose cytarabine |
| 2 | ACTIVE_COMPARATOR | Placebo plus low dose cytarabine |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| lenalidomide | DRUG | 10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle |
Inclusion Criteria: * Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder. * After being informed of the potential benefits and risks of available treatment options, patients must have declined inten...
Lintuzumab is an investigational monoclonal antibody being studied for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It has been evaluated in clinical trials in patients with these blood cancers, including older adults with AML and patients with MDS, but it is not approved for commercial use.
Lintuzumab targets CD33, a cell surface antigen expressed on myeloid leukemia cells. By binding to CD33, the antibody is designed to direct immune-mediated destruction of CD33-positive cancer cells. This mechanism underlies its investigation in acute myeloid leukemia and myelodysplastic syndrome.
Lintuzumab is being developed by Pfizer, Inc. (ticker: PFE). The company has sponsored clinical trials of the drug in acute myeloid leukemia and myelodysplastic syndrome.
Lintuzumab is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 trial evaluated lintuzumab in combination with low-dose cytarabine in patients aged 60 and older with acute myeloid leukemia.
Lintuzumab has been studied in completed clinical trials including NCT00528333, a Phase 2 trial in acute myeloid leukemia, and NCT00502112, a Phase 1 trial in myelodysplastic syndrome. Another completed Phase 1 safety study was NCT00283114 in patients with AML, MDS, and related disorders.
Yes, lintuzumab is also known as SGN-33. SGN-33 was the original designation used during its development. Both names refer to the same anti-CD33 monoclonal antibody being studied in acute myeloid leukemia and myelodysplastic syndrome.