NCT01678404Unknown2 期
A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma
Korea Cancer Center Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with variable differentiation status, which is distributed to a variety of organs.
A high response rate and long term survival is possible through surgery or radiation therapy alone in the case of limited disease. However frequent relapse and progression is observed despite of long term survival. The treatment after relapse has not been established yet.
So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with MZL.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed marginal zone B-cell lymphoma
- •relapsed or refractory patients after treatment including chemotherapy, radiation therapy, and surgery
- •Eastern Cooperative Oncology Group performance status ≤ 2
- •age≥ 20 years
- •More than one measurable lesion (More than 2cm sized lesion in conventional CT scan, More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT )
- •Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min)
- •Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit)
- •Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕)
- •patient who agree the purpose and intention of this clinical trial
排除标准
- •recent (<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
- •hemodynamically unstable due to the recent (<12 months) history of severe heart disease such as myocardial infarction
- •acute complications of severe lung or metabolic disease
- •Combined severe neurological or psychiatric disease
- •Unrecovered from infection or other medical disease
- •Recent (<30 days) history of enrollment of other clinical trial
- •Pregnant or breast-feeding woman
- •women of childbearing potential and men not employing adequate contraception at least for 1 year
- •Previous history drug allergy to the content of 131I-rituximab
- •Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled)
研究组 & 干预措施
131I-rituximab
Experimental
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
干预措施: 131I-rituximab (Drug)
结局指标
主要结局
Overall response rate
时间窗: up to 5 years
International Working Group Response criteria
次要结局
- Response duration(up to 5 years)
- Progression free survival(up to 5 years)
- Overall survival(up to 5 years)
- Number of Adverse Events(up to 5 years)
研究者
研究点 (1)
Loading locations...
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