NCT03335098Unknown2 期
A Phase 2 Study to Evaluate the Efficacy of Bortezomib in Patients With De-novo Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 19 or older
- •Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma
- •Previously untreated with chemotherapy
- •ECOG performance status of 2 or lesser
- •Peripheral blood white blood cell count ≥ 3,500/uL
- •Peripheral blood neutrophil count ≥ 1,000/uL
- •Peripheral blood platelet count ≥ 20,000/uL
- •Peripheral blood hemoglobin ≥ 6.0g/dL
- •Serum total bilirubin ≤ 2.0 mg/dL
- •Serum aspartate aminotransferase ≤ 2.5 x (upper normal limit)
- •Serum alanine aminotransferase ≤ 2.5 x (upper normal limit)
排除标准
- •Diagnosed with other malignancy within 5 years before enrollment
- •Prior hematopoietic stem cell transplantation
- •Prior organ transplantation
- •Uncontrolled central nervous system involvement
- •Congenital immunodeficiency
- •Acquired immune deficiency syndrome (AIDS)
- •Pregnancy
- •Uncontrolled epilepsy
- •Uncontrolled psychological disease
- •Peripheral neuropathy of grade 3 or higher
研究组 & 干预措施
Study arm
Experimental
Subcutaneous bortezomib 1.3mg/m2 on days 1, 4, 8, and 11 (every 4 weeks, up to 6 cycles) Oral thalidomide 50mg daily on days 1-28 (every 4 weeks, up to 6 cycles) Intravenous or oral dexamethasone 40mg on days 1-4 (every 4 weeks, up to 6 cycles)
干预措施: Bortezomib (Drug)
结局指标
主要结局
Overall response rate
时间窗: at 3 years
Overall response rate as per Lugano criteria
次要结局
- Progression-free survival(at 3 years)
- Overall survival(at 3 years)
研究者
Youngil Koh
Assistant professor
Seoul National University Hospital
研究点 (2)
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