A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage Ⅲ/Ⅳ NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.
详细描述
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage Ⅲ/Ⅳ NK/T cell lymphoma.
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
- •Histological confirmed NK/T cell lymphoma
- •None of chemotherapy or radiotherapy has been previously used
- •None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups )
- •At least one measurable lesion
- •None of other serious diseases, cardiopulmonary function is normal
- •Pregnancy test of women at reproductive age must be negative
- •Patients could be followed up
- •None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- •volunteers who signed informed consent.
排除标准
- •Disagreement on blood sample collection
- •Patients allergic of any of drug in this regimen or with metabolic disorder
- •Pregnant or lactating women
- •Serious medical illness likely to interfere with participation
- •Serious infection
- •Primitive or secondary tumors of central nervous system
- •Chemotherapy or radiotherapy contraindication
- •The evidence of CNS metastasis
- •History of peripheral nervous disorder or dysphrenia
- •patients participating in other clinical trials
- •patients taking other antitumor drugs
- •patients estimated to be unsuitable by investigator
研究组 & 干预措施
DDGP regiment
DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
干预措施: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) (Drug)
SMILE Regiment
Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment
干预措施: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna） (Drug)
结局指标
主要结局
Progression-free survival
时间窗: up to end of follow-up-phase (approximately 24 months)
次要结局
- median survival time(24 months)
- response rate(every 6 weeks,up to completion of treatment(approximately 18 weeks ))
- overall survival(up to the date of death (approximately 5 years))
研究者
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University