A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- RR
研究概览
简要总结
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.
详细描述
This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).
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
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 14~60 years; ECOG rate ≤ 2; expected survival > 3 months;
- •patients with T-lymphoblastic lymphoma diagnosed by histopathology detection;
- •patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells;
- •patients with no chemotherapy contraindications: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥1.5 x 109/L, blood platelet ≥100 x 109/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 ≥ 30 g/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
Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B.
干预措施: CODOX-M/IVAC (Combination Product)
Arm A
Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B.
干预措施: Decitabine (Drug)
结局指标
主要结局
RR
时间窗: up to 2 months
Responder Rate
TTP
时间窗: up to 2 months
Time To Progression
次要结局
- OS(up to 2 months)
- MST(up to 2 months)
研究者
Mingzhi Zhang
The director of oncology department of the first affiliated hospital
Zhengzhou University