Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 485
- 主要终点
- Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
研究概览
简要总结
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have diagnosed acute myeloid leukemia.
- •Must have a life expectancy of at least 12 weeks.
- •Must sign informed consent.
排除标准
- •Must not have acute promyelocytic leukemia (M3 classification)
- •Must not have any other active systemic malignancies.
- •Must not have inaspirable bone marrow.
- •Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
- •Must not have chronic respiratory disease that requires continuous oxygen use.
- •Must not have received any experimental drug within 4 weeks before randomization.
- •Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
- •Must not have known HIV.
研究组 & 干预措施
A
Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.)
干预措施: Cytarabine or Supportive Care (Drug)
B
干预措施: Dacogen (decitabine) only (Drug)
结局指标
主要结局
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
时间窗: The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
次要结局
- Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)(Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months))