NCT07552324尚未招募2 期
Study on the Treatment of Double/Triple-hit Diffuse Large B-cell Lymphoma With Chidamide and Lisaftoclax in Combination With Vepesidil, Rituximab, Cyclophosphamide, Adriamycin, and Prednisone (CL-Pola-R-CHP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Complete remission (CR) rate
研究概览
简要总结
This is an open-label, multicenter clinical study for patients aged 65 and above with double/triple-hit diffuse large B-cell lymphoma who are not suitable for transplantation. The study employs a 6-cycle CL-Pola-R-CHP regimen, with cycles repeated every 21 days.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
- •Double or triple hit confirmed by pathology;
- •Age ≥ 65 years old;
- •ECOG performance status score of 0, 1, or 2;
- •No history of malignant tumor; no concurrent occurrence of other tumors;
- •Patients whose life expectancy is at least 6 months, as determined by the researcher;
- •The patient or their legal guardian must provide written informed consent before undergoing any special examinations or procedures in the study.
- •International Prognostic Index (IPI) > 1 point.
排除标准
- •There is a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
- •Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
- •Primary central nervous system lymphoma;
- •Left ventricular ejection fraction (LVEF) is less than or equal to 50%;
- •Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count <1.5*10^9/L; B. Platelet count <75*10^9/L; C. ALT or AST is more than twice the upper limit of normal, and AKP and bilirubin are more than 1.5 times the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;
- •Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.
- •Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- •Pregnant or lactating women;
- •HIV-infected individuals.
- •Patients with positive HBsAg test results must undergo HBV DNA testing and can only be enrolled after becoming negative. Additionally, if the HBsAg test result is negative but the HBcAb test result is positive (regardless of the HBsAb status), HBV DNA testing is also required. If the result is positive, treatment must be administered until becoming negative before enrollment;
研究组 & 干预措施
Treatment Group
Experimental
CL-Pola-R-CHP
干预措施: CL-Pola-R-CHP (Drug)
结局指标
主要结局
Complete remission (CR) rate
时间窗: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
次要结局
- 1-year progression-free survival (PFS) rate(1 years after enrollment)
- 2-year overall survival (OS) rate(2 years after enrollment)
研究者
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