Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- objective response rate（ORR）
研究概览
简要总结
Study of Chidamide as a single-agent treatment for patients with relapse or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
详细描述
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). Moreover, the aim was to study the correlation of clinical efficacy to mutation of certain genes as well.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";
- •Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;
- •At least one measurable lesion;
- •Age 18-75 years, male or female;
- •ECOG performance status 0-1;
- •Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.
- •Life expectancy no less than 3 months;
- •Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;
- •Patients have signed the Informed Consent Form.
排除标准
- •Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
- •QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
- •pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
- •Patients have undergone organ transplantation;
- •Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- •Patients with active hemorrhage.
- •Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
- •Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- •Had major organ surgery within 6 weeks prior to enrollment.
- •Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
- •Patients with mental disorders or those do not have the ability to consent.
- •Patients with drug abuse, long term alcoholism that may impact the results of the trial.
- •Patients who have central nervous system involvements;
- •Non-appropriate patients for the trial according to the judgment of the investigators.
研究组 & 干预措施
Experimental
Drug: Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
干预措施: Chidamide (Drug)
结局指标
主要结局
objective response rate（ORR）
时间窗: up to 2 years
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
次要结局
- overall survival（OS）(2 years)
- Disease Control Rate （DCR）(up to 2 years)
- progression-free survival（PFS）(2 years)
研究者
Shi Yuankai
vice president
Chinese Academy of Medical Sciences