NCT01961882已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 134
- 主要终点
- Disease-Free Survival
研究概览
简要总结
To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
- •Patients who are 60 years or older.
- •Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.
排除标准
- •Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12), (PML/RARA) karyotype abnormalities, and other variant types.
- •Patients who are scheduled for hematopoietic stem cell transplantation.
- •Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial.
- •Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
- •Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic hepatitis C with positive HCV antibody.
- •Patients who have cirrhosis.
- •Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.
研究组 & 干预措施
OCV-501 arm
Experimental
干预措施: OCV-501 (Drug)
Placebo arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Disease-Free Survival
时间窗: 2 years (treatment period)
Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.
次要结局
- Overall Survival(2 years (treatment period))
研究者
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