Multicenter, Single-Arm, Open-Label Clinical Study to Observe the Efficacy of Chidamide Combined With Azacitidine, Prednisone, Cyclophosphamide, and Thalidomide in Patients With Peripheral T-Cell Lymphoma (PTCL) Who Are Intolerant to Standard Chemotherapy.

The First Affiliated Hospital with Nanjing Medical University1 个研究点分布在 1 个国家目标入组 58 人开始时间: 2026年8月1日最近更新: 2026年8月5日

适应症

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方: The First Affiliated Hospital with Nanjing Medical University
入组人数: 58
试验地点: 1
主要终点: Objective Response Rate（ORR）

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a multicenter, single-arm, non-randomized, open-label trial designed to evaluate the efficacy and safety of chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) in patients with peripheral T-cell lymphoma (PTCL). A total of 58 patients with PTCL are planned to be enrolled after providing written informed consent and meeting all eligibility criteria. Enrolled patients will receive the CAPCT regimen, with each cycle consisting of 21 days, for a total of 6 cycles. Participants who do not experience disease progression or unacceptable toxicity after 6 cycles of combination therapy will continue to receive the CPCT regimen (chidamide combined with prednisone, cyclophosphamide, and thalidomide) for up to 6 months, followed by chidamide monotherapy as maintenance treatment. The primary efficacy endpoint is objective response rate (ORR).

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

•1. Patients with histopathologically confirmed peripheral T-cell lymphoma (PTCL), with exclusion of NK/T-cell lymphoma.
•2. Patients who are treatment-naïve or have relapsed/refractory disease.
•3. Patients who are intolerant to standard chemotherapy regimens for various reasons, including those aged ≥75 years, or those aged <75 years but deemed by the investigator to be unsuitable for or unable to tolerate chemotherapy.
•4. Patients aged ≥18 years, male or female.
•5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
•6. Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥50×10⁹/L, and hemoglobin ≥70 g/L.
•7. Estimated life expectancy ≥3 months.
•8. Voluntary signing of written informed consent.

排除标准

•1. Pregnant or lactating women, or fertile patients of childbearing potential who are unwilling to adopt contraceptive measures.
•2. Patients with chronic heart failure of New York Heart Association (NYHA) functional class III or IV; or those with a history of any of the following cardiac conditions within 6 months: acute coronary syndrome; acute heart failure (NYHA functional class III or IV); or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or sudden cardiac death after resuscitation).
•3. Hepatic dysfunction (total bilirubin >1.5× the upper limit of normal [ULN]; alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >2.0× ULN, or >5× ULN in patients with hepatic involvement); or renal dysfunction (serum creatinine >1.5× ULN).
•4. Confirmed central nervous system (CNS) involvement by lymphoma.
•5. Receipt of prior myelosuppressive symptomatic treatment within 7 days before enrollment.
•6. Active hemorrhage/bleeding.
•7. Patients with acquired immunodeficiency syndrome (AIDS), syphilis, or active hepatitis B (HBV DNA >1×10⁵ copies/mL) or hepatitis C.
•8. Receipt of grade II or higher surgery within 3 weeks prior to treatment.
•9. Psychiatric disorders or inability to provide informed consent.
•10. Patients deemed by the investigator to be unsuitable for participation in this trial.
•11. Known allergy to any component of the investigational drug.