A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 637
- 试验地点
- 277
- 主要终点
- 2-year Disease-free Survival (DFS)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. 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. 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.
PURPOSE: 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.
详细描述
OBJECTIVES:
- Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy.
- Compare the complete remission rate in patients treated with these regimens.
- Compare the frequency and severity of the toxic effects of these regimens in these patients.
Other objectives (if funding allows):
- Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin.
- Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens.
- Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens.
- Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified during induction therapy according to age (< 35 years vs ≥ 35 years) and during post-consolidation therapy according to preinduction cytogenetic risk group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Post-consolidation GO
Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: gemtuzumab ozogamicin (Drug)
Post-consolidation observation
Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.
干预措施: observation (Other)
Induction 7+3
Standard induction regimen of 7 days of Ara-C (cytosine arabinoside) and 3 days of daunomycin
干预措施: Cytosine arabinoside (Drug)
Induction 7+3
Standard induction regimen of 7 days of Ara-C (cytosine arabinoside) and 3 days of daunomycin
干预措施: Daunomycin (Drug)
Induction 7+3+GO
Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C and 3 days of daunomycin
干预措施: Cytosine arabinoside (Drug)
Induction 7+3+GO
Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C and 3 days of daunomycin
干预措施: Daunomycin (Drug)
结局指标
主要结局
2-year Disease-free Survival (DFS)
时间窗: After completing any treatment, every 6 months for 2 years, than annually for years 3-5
Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.
Complete Remission
时间窗: After induction therapy was completed (1 or 2 months)
次要结局
- Toxicity(For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.)