Pragmatic Clinical Trial of Matching Malignant Hematologic Cancer Patients With Adequate Early Phase Clinical Trials by Next-generation Sequencing
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
A molecular profile of a patient with hematologic malignancy, for whom standard-of-care had failed, is identified using next generation sequencing. Patients are assigned to early clinical trials of targeted agent based on the molecular profiling or physician's choice. The improvement of outcomes in the intention-to-treat population is investigated.
详细描述
Most of hematologic malignancy patient becomes incurable with standard treatment during their disease course. Although these patients are recommended to participate in an early phase clinical trials, the response rate have reported be only 4 to 6 percent. Over several decades, a lot of cancer driving mutations has been identified, and targeted agents directed at the mutations are continuously developed and studied in many clinical trials. Most of the clinical trials recruited participants regardless of mutational status of them. Recently, however, participants has been recruited in recent clinical trials according to the presence of specific mutations. The response rate of these recent clinical trials is 12-75%.
In this pragmatic clinical trial, cancer driving mutations in hematologic malignancy patients is identified using next generation sequencing, and assign patients to an appropriate clinical trial which is anticipated to exhibit the best response. The improvement of outcome of this biomarker-driven assignment is investigated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults with > 18 years old
- •incurable hematologic malignancy patients who failed to respond to standard treatment
- •patients who agreed to this protocol with informed consent
- •Eastern Cooperative Oncology Group performance status ≤ 3
- •Tolerable major organ function determined by laboratory examination
排除标准
- •Expected survival < 3 months
- •patients with poor compliance
- •patients who can not give an informed consent
- •patients who are participating another clinical trials
研究组 & 干预措施
Matched
A molecular profile is identified using next generation sequencing. A participant in this arm is assigned to early clinical trial studying targeted agent, which is anticipated to have the best response rate.
干预措施: Matching on the basis of molecular analysis (Other)
Not matched
A participants in this arm is assigned to a clinical trial at physician's choice.
干预措施: Matching on the basis of physician's choice (Other)
结局指标
主要结局
Response rate
时间窗: one year
Response evaluation is based on the criteria suggested in a clinical trial to which a participant is assigned.
次要结局
- Overall survival(one year)
- Toxicity profile(one year)
- Progression-free survival(one year)
- Types of identified molecular profile(one year)
- Frequencies of identified molecular profile(one year)
研究者
Youngil Koh
Assistant professor
Seoul National University Hospital