S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML (NCT00085709)
Drugs used in chemotherapy, such as cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals) and daunorubicin (DaunoXome®; Gilead Sciences Inc.), work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibody-drug conjugates or ADCs such as gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories), can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.
This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.
- Condition: Leukemia
- Phase: III
- Enrollment: 637
- Start: July 2004
- Study Completion: August 2014
- Last verified: March 2015
Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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