NCT03297697已完成不适用
A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by progression-free survival (PFS) at the completion of 2 years
研究概览
简要总结
As T-cell receptor sequencing by LymphoTrack is an assay with high sensitivity that can be performed in peripheral blood, the investigators wish to evaluate the ability of this assay to predict which patients are at higher risk of relapse after initial therapy for peripheral T-cell lymphomas which is being given for curative intent. Additionally, as more is known about the ability of dynamic monitoring of cfDNA in B-cell lymphomas to predict relapse, the investigators wish to explore the use of this technology in T-cell lymphomas.
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
- •At least 18 years of age.
- •Histologically-confirmed peripheral T-cell lymphoma being treated with curative intent. Eligible histologies include, but are not limited to: peripheral T-cell lymphoma, not otherwise specified; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma, ALK negative; and anaplastic large cell lymphoma, ALK positive.
- •Plan for treatment with frontline multi-agent anthracycline containing chemotherapy for curative intent (for example, CHOP, CHOEP, EPOCH). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
- •Availability of pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype, or willingness to undergo biopsy if sufficient tissue is not available at time of enrollment (e.g. 15 slides from fixed formalin-fixed paraffin embedded tumor tissue
- •*Patients who have less than 15 slides of fixed formalin-fixed paraffin embedded tumor tissue may be considered for enrollment after discussion with the study principal investigator
- •Able to understand and willing to sign an IRB approved written informed consent document.
排除标准
- •Receiving second line of therapy or greater.
- •Diagnosis of primary cutaneous T-cell lymphoma, extranodal NK-cell lymphoma, acute T-cell lymphoma/leukemia, hepatosplenic T-cell lymphoma.
结局指标
主要结局
Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by progression-free survival (PFS) at the completion of 2 years
时间窗: 2 years
次要结局
- Rate of decline of the tumor specific sequence or sequences predict duration of response(Through 2 years)
- Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen(Baseline)
- Evaluate whether LymphoTrack TCR clonality assay can distinguish participants with peripheral T-cell lymphomas (PTCL) who are at risk of relapse(Through 2 years)
- Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment(Through 2 years)
- Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by the ability of Lymphotrack to detect minimal residual disease in at least 60% of baseline samples(Baseline)
- Characterize the lead time from MRD positivity to subsequent clinical relapse(Through 2 years)
研究者
研究点 (3)
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