drugset / Trial / NCT00049179
S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.
Timeline
- Start
- 2003-04
- Primary completion
- 2005-12
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | 4 mg/m2 | Intravenous |
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | 6 mg/m2 | Intravenous |