A Real-world Study on Golidocitinib-based Therapeutic Regimens for the Treatment of Patients With Peripheral T-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Objective Response Rate
研究概览
简要总结
This real-world study aims to evaluate the safety and efficacy of golidocitinib-based treatment regimens in patients with peripheral T-cell lymphoma (PTCL), without intervention in the selection of therapeutic strategies. A total of 1,000 PTCL patients are planned to be enrolled. After screening, eligible participants meeting the inclusion and exclusion criteria will be assigned to one of three predefined cohorts:
Cohort 1: Treatment-naïve patients with PTCL or NK/T-cell lymphoma.
Cohort 2: Patients receiving maintenance therapy following remission after first-line induction treatment for PTCL.
Cohort 3: Patients with relapsed or refractory PTCL or relapsed/refractory NK/T-cell lymphoma.
There is no cap on the number of participants in each cohort.
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
- •Voluntarily sign and acknowledge understanding of the Informed Consent Form
- •Clinically confirmed diagnosis of peripheral T-cell lymphoma
- •Inclusion of PTCL patients who initiated a Golidocitinib-based treatment regimen within the past 3 months
- •Compliance with clinical management and provision of disease-related historical medical information required for the study, including but not limited to medical records, treatment history, and prior/prescribed therapeutic regimens
排除标准
- •Poor patient adherence
- •Investigator-deemed ineligibility for enrollment
结局指标
主要结局
Objective Response Rate
时间窗: up to 24 weeks after enrollment
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria during the treatment
Safety such as adverse events
时间窗: up to 4 weeks after the last dose
Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with lymphoma receiving Golidocitinib therapy
次要结局
- Duration of Response(Baseline up to data cut-off(up to approximately 3 years))
- Progression-free survival(Baseline up to data cut-off(up to approximately 3 years))
- Overall survival(Baseline up to data cut-off(up to approximately 3 years))