NCT02633111进行中（未招募）不适用
DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 501
- 试验地点
- 11
- 主要终点
- MRD assay to predict clinical relapse
研究概览
简要总结
The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy in the future.
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
- •18 years of age at time of signing informed consent
- •Histology-confirmed aggressive B-cell Non-Hodgkin lymphoma
- •De novo diffuse large B-cell lymphoma (including all subtypes such as primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma). According to the 2008 WHO Classification of Hematopoietic and Lymphoid Tumors. These would include double or triple-hit diffuse large B-cell lymphomas with MYC/BCL2 and/or BCL6 gene rearrangements. These cases may be classified as high grade B-cell lymphomas according to the 2017 revision of the WHO Classification of Hematopoietic and Lymphoid Tumors.
- •Recipient of frontline multi-agent chemotherapy (for example, RCHOP, dose adjusted-REPOCH, RCHOP/RICE, RCHOP+investigational agent, etc). Eligible patients will have recently received (≤ 4 months from end of treatment assessment), be actively receiving, or planned to receive frontline chemotherapy in near future (within 3 months of signing consent). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
- •Required pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype.
- •Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and MRD test specimen collection at specified time points.
排除标准
- •Patients receiving 2nd or greater line of therapy.
- •Stage I or II disease.
- •Primary mediastinal B-cell lymphoma.
- •Transformation from antecedent or coincident indolent B-cell Non-Hodgkin lymphoma.
结局指标
主要结局
MRD assay to predict clinical relapse
时间窗: 2 years
using the Sequenta diagnostic tool prior to detection using the conventional means (clinical exams and scans) in DLBCL patients.
次要结局
未报告次要终点
研究者
研究点 (11)
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