A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TTP
研究概览
简要总结
To explore the safety, tolerability and clinical effects of decitabine combined with R±DHAP for patients with replase and refractory Diffuse Large B cell lymphoma.
详细描述
This is a randomized,controlled,prospective,open,multi-center clinical trial,amied to evaluate the safety, tolerability,and efficacy of decitabine combined with R±DHAP in replase and refractory Diffuse Large B cell lymphoma.A total of 60 patients are planned to be enrolled into the study.Patients with diagnosis of replase and refractory Diffuse Large B cell lymphoma will be into two groups,and be treated with decitabine pluse R±DHAP or only R±DHAP,respectively.The primary end points are objective responder rate(ORR) and time to progression(TTP) and the secondary end points include overall survival(OS) and progression free survival(PFS).
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:14-65 years;ECOG rate≤2;expected survival≥3 months
- •patients with Diffuse Large B cell lymphoma diagnoesd by histopathology detection;
- •patients ever received RCHOP or CHOP chemotherapy but did not receive DHAP
- •patients never received radiotherapy
- •patients with no chemotherapy contraindications:hemoglobin ≥ 90g/L,absoluate neutrophil count ≥1.5x109/L,blood platelet ≥100x109/L,ALT and AST ≤ 2-fold upper normal limit,serum bilirubin ≤1.5-fold upper normal limit,serum creatinine ≤1.5-fold upper normal limit,serum albumin ≥ 30g/L,normal serofibrinogen;
- •at least one measurable nidus;
- •no other severe diseases conflict with this project,cardiopulmonary function is basically normal
- •the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit;
- •applicable for follow-up visit;
- •no other antitumor adjoint therapy(including antitumor Chinese medicine,immunotherapy and biotherapy),but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable;
- •understanding this study and assigning informed consent.
排除标准
- •rejecting providing blood preparation;
- •allergic to drug in this study and with metabolic block;
- •rejecting adopting reliable contraceptive method in pregnancy or lactation period;
- •uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）；
- •with severe infection;
- •with primary or secondary central nervous system tumor invasion;
- •with immunotherapy or radiotherapy contraindication;
- •ever suffered with malignant tumor;
- •having peripheral nervous system disorder or dysphrenia;
- •with no legal capacity,medical or ethical reasons affecting research proceeding;
- •participating other clinical trials simultaneously;
- •adopting other anti-tumor medicine excluding this research;
- •the researchers considering it inappropriate to participate in the study.
研究组 & 干预措施
Arm A
R±DHAP + decitabine:
decitabine:10mg/d,ivgtt,d(-5)-(-1);R±DHAP:rituximab,375mg/m2,d0,ivgtt;cytarabine,2g/m2,q12h,d2,ivgtt;cisplatin,100mg/m2,used for 3 days,ivgtt;dexamethasone,40mg,d1-4,ivgtt/po.21 days for one cycle.
干预措施: Decitabine (Drug)
结局指标
主要结局
TTP
时间窗: up to 2 months
Time TO Progression
ORR
时间窗: up to 2 months
Objective Responder Rate
次要结局
- PFS(up to 2 months)
- OS(up to 2 months)
研究者
Mingzhi Zhang
The director of oncology department of the first affiliated hospital
Zhengzhou University