NCT00846157Unknown3 期
R-CHOP Therapy Compared With R-CHOP Plus Biocell Natural Killer Mixture in Patients With DLBCL (Diffuse Large B Cell Lymphoma);A Randomized, Open-label,Multi-center Trail
NKBio Co.Ltd.1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Event Free survival
研究概览
简要总结
Primary objective:
- To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell to R-CHOP therapy with DLBCL patients.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women of the age between 20 and 70
- •The patients who have measurable lesion using radiograph and have not received chemotherapy and radiation therapy after confirming DCBCL.
- •The patients with Ann arbor Ⅰ, Ⅱ, Ⅲ, Ⅳ
- •The patients who have not received NK / T-Cell lymphocyte therapy.
- •The patients who are expected to survive for at least 3 months.
- •The patients who or whose representative voluntary have written informed consent before performance of any study-related procedure.
- •Women of child bearing potential must have a negative pregnancy test within 7 days prior to study registration and agree to use adequate birth control during study treatment.
- •The patients with ADL classification (ECOG) scale 0, 1, 2
- •Patients who satisfy following hematologic criteria
- •WBC ≥ 3,000 / ㎕
- •platelet count ≥ 75,000 / ㎕
- •serum total bilirubin ≤ two times of upper limit of normal values of each laboratory
- •serum creatinine ≤ two times of upper limit of normal values of each laboratory
- •lymphoma patients who satisfy the following criteria
- •good renal function (GFR> 50)
- •good hepatic function (total bilirubin level ≤ three times of upper limit of normal values of each test laboratory transaminases ≤ 5 times of the upper limit of normal value of each testing laboratory)
- •The patients with negative HIV surface antigen
- •The patients with negative HBV
- •The patients with negative HCV
- •The patients who have not received immunotherapy.
- •The patients who have not experienced tuberculosis infection within recent 6 months.
排除标准
- •The minors under 20 years of age (In accordance with Civil Code)
- •The patients diagnosed with other types of lymphoma
- •The patients who have central nervous system or meningeal involvement by lymphoma.
- •The patients who have contraindication of chemotherapy regimen
- •The patients with another active severe disease.
- •The patients who have history of cancer within 5 years
- •Uncontrolled hypertension patients
- •The patients who have hypersensitivity to Erythropoietin.
- •The patients who have the following diseases or the experience to have following disease within 3 months.
- •Myocardial infarction
- •Unstable coronary disease
- •Uncontrolled cardiac insufficiency.
- •Venous thrombosis
- •Pulmonary embolism
- •The patients who have experience to be treated with the pharmaceutical for clinical trials.
- •Pregnant and lactating women or women of childbearing age not using adequate contraceptive method.
- •The patients with clinically serious bacterial, viral or fungal infection
- •The patients of the test group who have the problem in NK cell cultures (Investigator will decide on this criteria with basis generated during NK cell culture)
- •Patients with autoimmune diseases
- •The patients who underwent visceral resection related with Lymphoma.
结局指标
主要结局
Event Free survival
时间窗: 3 years
次要结局
- Progression free survival(3 years)
研究者
研究点 (1)
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