Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Progression-free survival
研究概览
简要总结
A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.
详细描述
Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. This multi-center, prospective, registry study is designed to analyze the clinical characteristics and prognosis of different molecular subtypes of PTCL. The results can guide future precision therapy for PTCL.
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
- •Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2023 to December 2026 and detected by gene sequencing (NGS) with different molecular subtypes.
- •Patients diagnosed with PTCL by histopathology from January 2023 to June 2023 and NGS detection can be performed if there is tumor tissue.
- •Informed consented
- •Age ≥ 18 years
排除标准
- •History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Not able to comply to the protocol for mental or other unknown reasons
- •Patients with mentally disorders or other reasons unable to fully comply with the study protocol
- •Pregnant or lactation
结局指标
主要结局
Progression-free survival
时间窗: Baseline up to data cut-off (up to approximately 2 years)
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
次要结局
- Overall response rate(End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days])
- Overall survival(Baseline up to data cut-off (up to approximately 4 years))
- complete response rate(End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days])
- Tumor tissue gene mutations analysis(Baseline up to data cut-off (up to approximately 4 years))
- Circulating free Deoxyribonucleic Acid (cfDNA) monitoring(Baseline up to data cut-off (up to approximately 4 years))
- Duration of response(Baseline up to data cut-off (up to approximately 4 years))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Baseline up to data cut-off (up to approximately 4 years))
研究者
Zhao Weili
Deputy Director of Hospital, Shanghai Rui Jin Hospital
Ruijin Hospital