NCT01678417Unknown2 期
A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
Korea Cancer Center Hospital1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年6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
- 29
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has relatively good prognosis, continual treatment is needed due to frequent relapse. FL with histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma. Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with FL or MCL
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 follicular lymphoma or mantle cell lymphoma
- •relapsed or refractory patients
- •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
次要结局
- progression free survival(up to 5 years)
- Response duration(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)
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