Dynamic Monitoring of Plasma Circulating Tumor DNA (ctDNA) for Prognostic Assessment in Patients With B-Cell Non-Hodgkin Lymphoma: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
For patients with newly diagnosed or relapsed/metastatic B-cell non-Hodgkin lymphoma following first-line treatment, peripheral blood samples are collected before treatment and at various treatment time points to monitor circulating tumor DNA (ctDNA), aiming to investigate the correlation between dynamic ctDNA changes and patient prognosis.
详细描述
This study is a prospective, observational, single-center clinical research aimed at exploring the correlation between the dynamic changes of plasma circulating tumor DNA (ctDNA) before and after treatment and the prognosis of patients with B-cell non-Hodgkin's lymphoma (B-NHL). A total of 60 patients who were initially treated with evaluable target lesions and were capable of undergoing molecular pathological testing, either in the initial treatment stage or after relapse/refractory treatment, were planned to be included. All patients will provide peripheral blood samples for ctDNA testing at the pre-treatment stage, during the mid-treatment stage, and after the end of treatment. Simultaneously, standard efficacy assessment PET-CT examinations will be conducted. The primary endpoint of the study is progression-free survival (PFS), while the secondary endpoints include overall response rate (ORR), overall survival (OS), and the consistency analysis between ctDNA clearance rate and PET-CT metabolic complete response (CMR).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years and ≤ 75 years.
- •Histopathologically and immunohistochemically confirmed diagnosis of B-cell non-Hodgkin lymphoma (according to the latest WHO classification).
- •Presence of at least one evaluable target lesion prior to initial treatment (based on Lugano 2014 criteria).
- •Availability of feasible tumor tissue samples or fresh biopsy specimens (from initial diagnosis or relapse biopsy) for establishing a personalized sequencing assay (e.g., identification of patient-specific mutations via tumor tissue DNA sequencing for ctDNA tracking).
- •Planned to receive standard regimen therapy (first-line regimen for treatment-naïve patients, second-line regimen for relapsed/refractory patients).
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Voluntary participation in this study with written informed consent provided.
排除标准
- •Prior treatment with ≥2 lines of systemic anti-lymphoma therapy.
- •Presence of other active malignancies
- •History of myocardial infarction within the past 1 year; presence of New York Heart Association (NYHA) class III or IV congestive heart failure, or a history of NYHA class III or IV congestive heart failure, unless left ventricular ejection fraction (LVEF) is ≥50% on echocardiography (ECHO) screening performed within 1 month prior to study entry.
- •Hepatic or renal dysfunction: creatinine level ≥176.8 μmol/L (2 mg/dL), transaminase or bilirubin levels >2 × upper limit of normal (ULN).
- •Severe hematologic abnormalities: absolute neutrophil count (ANC) <1 × 10⁹/L, platelet count <50 × 10⁹/L.
- •Presence of uncontrolled infection.
- •Pregnant or breastfeeding women.
- •Any other condition that the investigator deems inappropriate for participation in this trial.
研究组 & 干预措施
patients with newly diagnosed B-cell non-Hodgkin lymphoma
Patients with untreated B-cell non-Hodgkin lymphoma
patients with newly relapsed/metastatic B-cell non-Hodgkin lymphoma
atients with relapsed or refractory non-Hodgkin B-cell lymphoma who have failed first-line therapy and are candidates for second-line treatment
结局指标
主要结局
PFS
时间窗: From enrollment to the end of treatment at 8 weeks
PFS defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first.
次要结局
- ORR(From enrollment to the end of treatment at 8 weeks)
- OS(From enrollment to the end of treatment at 8 weeks)
- Agreement between ctDNA clearance and PET-CT-defined metabolic complete response (CMR)(From enrollment to the end of treatment at 8 weeks)