Biologically Focused Therapy of Treatment Refractory MDS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Proportion of patients with successful ex vivo results
研究概览
简要总结
This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.
详细描述
This study utilizes the Notable Labs personalized testing service using an ex vivo assay, but does not involve actual treatment or treatment determinations. The results of these screenings will be made available to patients and their physicians for their use off study.
The primary objective of the study is:
• To determine the feasibility of selecting patient specific treatment regimens based on ex vivo within 30 days
The exploratory objectives of the study are:
• To identify biomarkers that explain ex vivo drug sensitivity results
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide informed consent;
- •Myelodysplastic syndrome as defined by WHO classification (see Appendix 2), or MDS/MPN with >= 5% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) 1 and 2 by WHO classification
- •Relapsed/refractory disease, defined as failed or are ineligible for hypomethylating agent therapy
- •Cytogenetics reported
排除标准
- •Hypoplastic MDS
- •Patients without adequate marrow samples for ex vivo analysis
结局指标
主要结局
Proportion of patients with successful ex vivo results
时间窗: 30 days
Proportion of patients with successful ex vivo results within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing
Proportion of patients with successful treatment decisions
时间窗: 30 days
Proportion of patients with successful treatment decisions made by the molecular oncology board within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing
次要结局
未报告次要终点