NCT02993536撤回不适用
Clonal Evolution of B Cells in High-risk Chronic Lymphocytic Leukemia Patients After Idelalisib-rituximab Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of somatic hypermutation
研究概览
简要总结
The purpose of the study is to assess the evolution of B cells at a genetic and surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will include patients with relapsed or refractory disease who require therapy with idelalisib and rituximab as per FDA label. This is an observational study for peripheral blood samples of these patients collected at pre-determined time points.
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
- 否
入选标准
- •Age over 18
- •Ability to provide informed consent
- •Ability to provide peripheral blood samples
- •Diagnosis of CLL
- •Indication(s) for CLL therapy
- •At least one criterion for high-risk disease
- •Disease refractory (e.g., no response) to at least one round of chemotherapy
- •Disease that has relapsed (i.e., returned) after at least one round of chemotherapy
- •Proven presence of the 17p deletion within CLL cells
- •Planned receipt of idelalisib-rituximab as per FDA guidelines and patient's oncologists
排除标准
- •Patients who do not meet the diagnostic criteria for CLL or at least one indication for treatment.
- •Patients who are receiving idelalisib with an off-label indication
- •Patients who do not or cannot provide informed consent to donate peripheral blood tumor samples to our stem cell core facility
- •Patients who do not provide informed consent to collect clinical, prognostic, and outcomes data during the time period that they are treated with idelalisib-rituximab
结局指标
主要结局
Number of somatic hypermutation
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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