NCT02840539已完成2 期
A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Overall response
研究概览
简要总结
The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed mantle cell lymphoma
- •Relapse or progression after 1-3 lines of previous chemotherapy with or without immunologic agents
- •ECOG performance status 2 or less
- •Adequate hematologic, hepatic, and renal function i. White blood cells ≥ 3,000 /ul ii. Absolute neutrophil count ≥ 1,000 /ul iii. Platelets ≥ 50,000 /ul iv. Hemoglobin ≥ 9.0 g/dL v. Total bilirubin < 2 times upper limit of normal vi. AST, ALT < 2.5 times upper limit of normal vii. Serum creatinine < 1.5 times upper limit of normal
排除标准
- •Previously treated with 4 or more lines of chemotherapy with or without immunologic agents
- •Previously treated with bortezomib
- •Treated with a cytarabine-containing regimen as the last line and within 6 months before registration
- •Other cancer diagnosed within 5 years before registration
- •Uncontrolled symptomatic CNS involvement of mantle cell lymphoma
- •Uncontrolled systemic infection
- •Inherited immunodeficiency disease or AIDS
- •Pregnancy
- •Breast-feeding
- •Peripheral neuropathy of grade 3 or higher
- •Other health conditions considered to be inappropriate for this trial in the primary physician's opinion
研究组 & 干预措施
Experimental
Experimental
Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
干预措施: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim (Drug)
结局指标
主要结局
Overall response
时间窗: within 28 days after the last cycle of treatment
Lugano classification
次要结局
- Complete response(within 28 days after the last cycle of treatment)
- Overall survival(5 years)
- Progression-free survival(5 years)
研究者
YOUNGIL KOH
Associate Professor
Seoul National University Hospital
研究点 (1)
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