Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary Outcome: Predicting Progression Free Survival
研究概览
简要总结
In this study, invesigators propose to analyze 150 DLBCL patients, 50 MCL patients, and 100 FL patients to determine the clinical utility of ctDNA- as well as circulating tumor cell (CTC)-based MRD assessment in CAR therapy patients. The project detailed in this protocol will utilize the clonoSEQ platform as specific quantification of residual DLBCL/FL/MCL and correlate its results with radiologic assessment of disease and clinical outcomes. Invesitgators predict there will be a strong correlation between ctDNA and PET/CT and dynamic changes in ctDNA will precede radiologic evidence of disease recurrence in patients following CAR therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Immunophenotypically confirmed diagnosis of follicular lymphoma (FL), Immunophenotypically confirmed diagnosis of Large B Cell Lymphoma (LBCL) (including transformed FL and Primary Mediastinal B-cell Lymphoma) OR Immunophenotypically confirmed diagnosis of mantle cell lymphoma (MCL) undergoing commercially approved CAR-T therapy in accordance with FDA indication with enrollment in this trial prior to CAR infusion
- •CAR-T product must meet manufacturer specifications
- •PET measurable disease at the time a decision is made to prescribe CAR treatment
- •Has sample from diagnosis or relapse available for genomic DNA extraction to identify patient's clonotype via clonoSEQ (see lab manual for details)
排除标准
- •Lack of archival diagnostic or fresh/archival relapse tissue for purposes of determining patient's lymphoma clonotype. Given that 5-10% of patients cannot have a clonotype identified by clonoSEQ, those patients will be removed from the study and excluded from analysis, but their samples will continued to be stored for future analysis as improvements to the analysis platform are made.
- •No patients are to be excluded on the basis of gender, race, ethnic background, sexual orientation, or other demographic characteristics.
结局指标
主要结局
Primary Outcome: Predicting Progression Free Survival
时间窗: 0-18 months
Ability of ctDNA MRD assessment to predict progression-free survival (PFS) at 6 months following CAR infusion in DLBCL, FL and MCL patients.
次要结局
- Secondary Objective: Correlation of minimal residual disease and tumor burden(0-18 months)
- Secondary Objective continued: Looking at clinical information of minimal residual disease(0-18 months)
- Secondary Objective continued: Additional correlations(0-18 months)