Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.
详细描述
Plan to enroll 51 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive PI3K inhibitor treatment (including Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).
排除标准
- •Here is the translated text:
- •Subjects who have previously used any PI3K inhibitors;
- •Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- •Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
- •Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- •HBV or HCV infection (defined as HBsAg and/or HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive;
- •History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation;
- •Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;
- •Presence of severe or uncontrolled cardiovascular disease;
- •Presence of severe concomitant diseases that endanger patient safety or are deemed by the investigator to affect the completion of the study (e.g., uncontrolled hypertension, diabetes, thyroid disease);
- •Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;
- •Diagnosed or treated for other malignancies within the past 5 years;
- •Any other condition that the investigator deems unsuitable for participation in the study.
研究组 & 干预措施
PI3K inhibitor
Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally
干预措施: PI3K inhibitor (Drug)
结局指标
主要结局
Overall response rate
时间窗: up to 5 years
complete remission rate+ partial remission rate
次要结局
- Overall survival(up to 5 years)
- Disease control rate(up to 5 years)
- Duration of remission(up to 5 years)
- Complete remession rate(up to 5 years)
- The safety of PI3K inhibitors(up to 5 years)
- Time to response(up to 5 years)
- Progression-free survival(up to 5 years)