A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 189
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.
PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given with or without gemtuzumab ozogamicin or tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.
详细描述
OBJECTIVES:
Primary (patients considered fit for intensive treatment)
- Compare the efficacy and toxicity of daunorubicin hydrochloride and cytarabine (DA) vs daunorubicin hydrochloride and clofarabine (DClo) as induction therapy in older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.
- Assess the value of gemtuzumab ozogamicin when given in combination with DA or DClo during course 1 of induction therapy.
- Compare a total of two vs three courses of treatment in patients who achieve at least partial remission (< 15% blasts) after course 1 of induction therapy.
- Compare the use of demethylation maintenance therapy comprising azacitidine vs no maintenance therapy in these patients.
- Assess the value of reduced-intensity allogeneic stem cell transplantation as consolidation in patients with matched donors.
Primary (patients considered unfit for intensive treatment)
- Compare the efficacy and toxicity of low-dose cytarabine with vs without gemtuzumab ozogamicin in these patients.
- Compare the efficacy and toxicity of low-dose cytarabine with vs without arsenic trioxide in these patients.
- Compare the efficacy and toxicity of low-dose cytarabine vs low-dose clofarabine in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 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
结局指标
主要结局
Overall survival
Achievement of complete remission and reasons for failure
Duration of remission, relapse rates, and deaths
Hematological and nonhematological toxicity
Supportive care requirements (and other aspects of health economics)
次要结局
未报告次要终点