A Non-randomized, Open-label, Phase II Study of Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Not Suitable for Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP （rituximab/gemcitabine/dexamethasone/cisplatin）in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.
详细描述
The treatment outcome of patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) are not satisfactory especially for those not suitable for transplantation. One of main reason is chemotherapy resistance. The investigators conducted this study to evaluate the efficacy of Chidamide combined with R-GDP(rituximab/gemcitabine/dexamethasone/cisplatin) in treating patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation. Chidamide is a novel benzamide type of subtype-selective histone deacetylase (HDAC) inhibitor. It has been approved by China Food and Drug Administration (CFDA) for treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in Chinese population. The investigators' pre-clinical data suggested that this agent might be also efficient in the treatment of relapsed/refractory B cell lymphoma. In this open-label, non-randomized, phase II study, the investigators aimed to observe the efficacy and safety of chidamide combined with R-GDP in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.
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
- •Ages: 18-75 years old
- •Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy
- •Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2
- •Informed consent available
- •Life expectancy of more than 3 months;
- •Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
- •Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;
- •Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit of normal value)
- •Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min
排除标准
- •Prior history of treatment of HDAC inhibitor.
- •Plan of HSCT in the future
- •Significant pericardial effusion showed by chest CT scan
- •Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation
- •Syphilis or human immunodeficiency virus (HIV) infection
- •Pregnant or lactating women
- •History of organ transplantation
- •Serious active infections (including hepatitis)
- •Serious neurological or psychiatric history, including dementia or epilepsy.
- •Termination criteria:
- •Withdrew consent
- •Researchers think it is necessary to terminate the study;
- •Disease progression or death;
- •Poor compliance
- •Subclinical or clinical cardiac toxicity;
- •Unable to continue treatment because of severe toxicity
研究组 & 干预措施
Chidamide combined with R-GDP
Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off
干预措施: Chidamide combined with R-GDP (Drug)
结局指标
主要结局
ORR
时间窗: 6 weeks
overall response rate
次要结局
- CR(6 weeks)
- OS(3 years)
- 3 year PFS(3 years)
- adverse event(throughout the treatment period，up to 6 months)