A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 78
- 主要终点
- Complete remission rate
研究概览
简要总结
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 high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid leukemia.
详细描述
OBJECTIVES:
- Determine the response rate in patients with relapsed or refractory acute myeloid leukemia treated with gemtuzumab ozogamicin (CMA-676) and high-dose cytarabine.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of gemtuzumab ozogamicin (CMA-676) (phase I closed to accrual effective 08/25/2003). Patients are stratified according to disease status (refractory vs relapsed).
-
Phase I (closed to accrual effective 08/25/2003): Patients are enrolled in one of four cohorts.
-
Cohort I (closed to accrual as of 10/1/02): Patients receive CMA-676 at the first dose level IV over 2 hours on days 1 and 8.
-
Cohort IA (open to accrual as of 10/15/02): Patients receive high-dose cytarabine (HD-ARA-C) IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7.
-
Cohort II: Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose level IV over 2 hours on days 7 and 14.
-
Cohort IV: Patients receive CMA-676 at the second dose level and HD-ARA-C as in cohort II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older 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
Cohort IA
Gemtuzumab + ara C
干预措施: ara-C (Drug)
Cohort I
Immunotherapy with gemtuzumab
干预措施: gemtuzumab ozogamicin (Biological)
Cohort II
Gemtuzumab + ara-C
干预措施: ara-C (Drug)
Cohort II
Gemtuzumab + ara-C
干预措施: gemtuzumab ozogamicin (Biological)
Cohort IA
Gemtuzumab + ara C
干预措施: gemtuzumab ozogamicin (Biological)
Cohort IV
Gemtuzumab + ara-C
干预措施: ara-C (Drug)
Cohort IV
Gemtuzumab + ara-C
干预措施: gemtuzumab ozogamicin (Biological)
结局指标
主要结局
Complete remission rate
时间窗: 8 or 14 days after tx initiation & 30 d post tx
次要结局
- Toxicity(D 14, then 30, 60 , & 90 d post Tx, q 3 mon for 1 yr, then at relapse or death)