NCT07493109招募中3 期
Evaluation of the Efficacy and Safety of Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP: A Prospective, Multicenter, Open-label Phase III Clinical Trial
Ou Bai, MD/PHD1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.
详细描述
Primary endpoint is 2-year progression-free survival (PFS). Secondary endpoints include overall survival (OS), safety parameters, and exploratory biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes, age range ≥18 years and ≤80 years.
- •No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy used to relieve tumor-related symptoms), or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma). Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy, confirmed by imaging (CT/PET-CT), bone marrow biopsy (if positive at baseline), and clinical assessment. Eligible patients will be randomly assigned in a 1:1 ratio to either the chidamide maintenance treatment group (experimental group) or the observation group (control group).
- •Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): Diffuse large B-cell lymphoma (DLBCL), and CD20-positive; Positive result for hepatitis B infection, defined as HBsAg positive, HBV DNA positive (>2000 IU/mL), or histopathological evidence of chronic HBV infection (without cirrhosis). Patients receiving ongoing antiviral therapy (e.g., nucleos(t)ide analogs) must have been on a stable regimen for ≥4 weeks prior to enrollment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks prior to assessment): Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis).
- •Life expectancy of at least 6 months, as judged by the investigator.
- •Understand and voluntarily sign a written informed consent form.
排除标准
- •Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
- •Patients with a history of clinically significant QTc interval prolongation (males > 450 ms, females > 470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), or symptomatic coronary artery disease requiring medication.
- •Patients who have undergone organ transplantation.
- •Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
- •Patients with active bleeding.
- •Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.
- •Patients with active infection, or persistent fever within 14 days before enrollment.
- •Patients who have not completed at least 6 weeks of recovery after major organ surgery.
- •Patients with abnormal liver function (total bilirubin > 1.5 × upper limit of normal [ULN], ALT/AST > 2.5 × ULN, or > 5 × ULN in patients with liver involvement) or abnormal renal function (serum creatinine > 1.5 × ULN).
- •Patients with mental disorders or those from whom informed consent cannot be obtained.
- •Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.
- •Patients with lymphoma involving the central nervous system (CNS).
- •Patients deemed by the investigator to be unsuitable for participation in this study.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 24 months
The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.
次要结局
- Overall Response Rate (ORR)(24 months)
- Overall survival（OS）(24 months)
研究者
Ou Bai, MD/PHD
Director
The First Hospital of Jilin University
研究点 (1)
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