S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)|
- CR [ Time Frame: After induction therapy is completed ] [ Designated as safety issue: No ]
|Study Start Date:||April 2003|
|Study Completion Date:||October 2010|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
- Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia.
- Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients.
- Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7.
- Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 10-28 months.