An Observational, Bidirectional Cohort Study to Evaluate T-cell Developmental Status in Patients With Malignant Hematological Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Percentages of TSP/RTE, TREC, and mature T-cell subsets，%
研究概览
简要总结
To evaluate the immune status and prognosis of patients with malignant hematological tumors, thereby guiding clinical therapeutic strategies.
详细描述
Primary Objective:
To evaluate the immune status and prognosis of patients with newly diagnosed or relapsed B-cell lymphoma and multiple myeloma by dynamically monitoring peripheral blood thymus seeding progenitors (TSP), recent thymic emigrants (RTE), T-cell receptor rearrangement excision circles (TREC), naive T-cells, and developmental/functional T-cell subsets before and after treatment, thereby guiding clinical therapeutic strategies.
Secondary Objective:
To monitor remission rates, survival outcomes, and infection rates in patients with hematological malignancies, and to explore their association with dynamic changes in developmental/functional T-cell subsets.
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 ≥ 18 years; both genders included; expected survival > 3 months;
- •Cohort 1: Patients with newly diagnosed or relapsed B-cell lymphoma confirmed by histopathology, bone marrow pathology, flow cytometry, morphology, and genetic testing; Cohort 2: Patients with newly diagnosed or relapsed multiple myeloma confirmed by the same methods; Cohort 3: Healthy volunteers;
- •Able to understand and voluntarily sign the informed consent form.
排除标准
- •Significant pulmonary disease:
- •Chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <50% of predicted normal value. Note: Suspected COPD cases require FEV1 testing; subjects with FEV1 <50% of predicted must be excluded.
- •Moderate/severe persistent asthma within the past 2 years, or currently uncontrolled asthma of any severity. (Note: Controlled intermittent or mild persistent asthma is permitted.)
- •Symptomatic congestive heart failure (NYHA Class II-IV), symptomatic/uncontrolled arrhythmias, congenital long QT syndrome, or corrected QT interval (QTc) >500 ms (Fridericia formula) at screening.
- •History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severely impaired lung function.
- •HIV infection (positive HIV-1/2 antibodies) or known syphilis infection.
- •Unhealed wounds, fractures, gastroduodenal ulcers, persistent fecal occult blood positivity, ulcerative colitis, or other conditions at risk of gastrointestinal bleeding/perforation (as determined by the investigator).
- •Severe neurological/psychiatric disorders, immunodeficiency, hepatitis/cirrhosis, or other conditions deemed unsuitable for study participation by the investigator.
结局指标
主要结局
Percentages of TSP/RTE, TREC, and mature T-cell subsets，%
时间窗: Up to 36 months
Dynamic changes in peripheral blood TSP/RTE, TREC, and mature T-cell subsets before treatment initiation, before the 2nd, 3rd, and 5th treatment cycles
次要结局
未报告次要终点
研究者
Zhijuan Lin
Principal Investigator
The First Affiliated Hospital of Xiamen University