NCT06550336进行中（未招募）2 期
A Prospective, Single-center, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Chidamide Monotherapy for Maintenance Therapy in CD30+ Peripheral T-cell Lymphoma (PTCL).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival (PFS) rate
研究概览
简要总结
- Objective:This study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) who have achieved remission or stable disease after initial brentuximab vedotin (BV) plus cyclophosphamide, doxorubicin and prednisone (CHP)treatment, excluding ALK+ anaplastic large-cell lymphoma (ALCL).
- Design: The study is a prospective, single-center, open-label clinical trial.
- Treatment:Eligible patients will receive Chidamide tablets at a dosage of 20 mg (4 tablets) twice weekly. Treatment cycles are 4 weeks long and will continue until disease progression, unacceptable toxicity, patient withdrawal, investigator decision to discontinue, loss to follow-up, death, or study termination.
- Endpoints:The primary endpoint is the 2-year progression-free survival (PFS). Secondary endpoints include the overall response rate (ORR), overall survival (OS), and safety indicators.
- Rationale:The study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients.
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
- •According to the WHO 2016 diagnostic criteria, the histological diagnosis is confirmed as CD30+ peripheral T-cell lymphoma (PTCL), including peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALK- ALCL), enteropathy-associated T-cell lymphoma (EATL), and other pathological subtypes (excluding extranodal NK/T-cell lymphoma, nasal type [NKTCL]). Patients with newly diagnosed PTCL (excluding ALK+ ALCL), who have completed 6 cycles of first-line treatment regimens (including various first-line induction chemotherapy regimens, targeted drugs, other treatment plans, and various combined therapies, etc.; with or without the inclusion of Chidamide) and have achieved complete remission (CR), and are not suitable for or do not consider undergoing autologous hematopoietic stem cell transplantation. Within 12 weeks from the first day of the last cycle of their first-line treatment regimen, they start to receive the medication plan of this study.
- •Age ≥18 years, male or female is not limited;
- •ECOG performance status score 0-3;
- •Neutrophils ≥1.5×10^9/L, platelets ≥80×10^9/L, hemoglobin ≥90g/L;
- •Expected survival time ≥3 months;
- •Voluntarily sign a written informed consent form.
排除标准
- •Pregnant or lactating women and women of childbearing age who are unwilling to adopt contraceptive measures;
- •Patients with a history of clinically significant prolongation of the QTc interval (males > 450ms, females > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), cardiac conduction block, myocardial infarction within the past year, congestive heart failure (CHF), and patients with symptomatic coronary artery disease requiring medication;
- •Patients who have undergone organ transplantation;
- •Patients who have received symptomatic treatment for previous bone marrow toxicity within 7 days prior to enrollment;
- •Patients with active bleeding;
- •Patients with a history of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related diseases;
- •Patients with active infection or those who have had persistent fever within 14 days prior to enrollment;
- •Patients who have undergone major organ surgery within the past 6 weeks;
- •Patients with abnormal liver function (total bilirubin > 1.5 times the normal value, ALT/AST > 2.5 times the normal value, or in liver-infiltrated patients ALT/AST > 5 times the normal value), and abnormal kidney function (serum creatinine > 1.5 times the normal value);
- •Patients with mental disorders/those who are unable to give informed consent;
- •Patients with drug abuse or chronic alcoholism that affects the evaluation of the trial results;
- •Patients with lymphoma involving the central nervous system;
- •Patients deemed by the investigator to be unsuitable for participation in this study.
研究组 & 干预措施
Chidamide maintenance arm
Experimental
20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25. It should be administered orally 30 minutes after meals.
干预措施: Chidamide (Drug)
结局指标
主要结局
2-year progression-free survival (PFS) rate
时间窗: 24months
PFS was defined as the time between diagnosis and the first date of relapse or all-cause death, whichever occurred first.
次要结局
- overall survival (OS)(48months)
研究者
Ou Bai, MD/PHD
Director
The First Hospital of Jilin University
研究点 (1)
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