An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination With Arsenic Trioxide Compared With Low-Dose Cytarabine Alone for the Treatment of Elderly Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Percentage of Participants in Complete Remission (CR)
研究概览
简要总结
The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has confirmed acute myeloid leukemia (AML).
- •The patient is unwilling or unable to tolerate conventional induction chemotherapy.
- •The patient has no comorbid conditions that would limit life expectancy to less than 3 months.
- •Patient must meet specific laboratory parameters for study inclusion.
排除标准
- •The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
- •Previous treatment with low-dose cytarabine is not permitted.
- •The patient has a QT interval outside of the protocol-specified range.
- •The patient has laboratory values outside of protocol-specified ranges.
- •The patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents.
- •The patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition.
- •The patient has known central nervous system involvement with AML.
研究组 & 干预措施
Low-dose cytarabine plus arsenic trioxide
Cycle 1 cytarabine 10 mg/m^2 was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2 A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
干预措施: Arsenic trioxide (Drug)
Low-dose cytarabine plus arsenic trioxide
Cycle 1 cytarabine 10 mg/m^2 was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2 A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
干预措施: Low-dose cytarabine alone (Drug)
Low-dose cytarabine alone
Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine was given to patients with persistent disease. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. Recovery period up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
干预措施: Low-dose cytarabine alone (Drug)
结局指标
主要结局
Percentage of Participants in Complete Remission (CR)
时间窗: From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator
The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.
次要结局
- Number of Participants Who Died or Were Censored by 24 Months(From Baseline through 24 months following Baseline)
- Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate(From Baseline (randomization) through 24 months following Baseline)
- Number of Participants Who Experienced Induction (Thirty-Day) Mortality(Up to 30 days following start of study drug treatment)
- Number of Participants Who Experienced Early Death(14 days from start of study drug treatment)
- Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate(Baseline through 12 months)