Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkin's Lymphoma - an Open-labeled Phase II Study
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
- Event-free survival
研究概览
简要总结
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.
详细描述
Title: Combining 90Y-Ibritumomab tiuxetan (Zevalin) with high-dose chemotherapy of BuCyE and autologous stem cell transplantation in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma - an open-labeled phase II study.
Study design: Prospective, multicenter, open-labeled, phase II trial.
Study objectives:
- Primary: event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma
- Secondary: overall survival response rate toxicity of the treatment combination
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
- — 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
- •Age < 65 years old
- •WHO performance status (PS) of 0-2
- •ANC > 1,500/mm3, platelet > 100,000/mm3
- •Cr < 2.0 mg% or Ccr > 50 mL/min
- •Transaminase < 3X upper normal value
- •Bilirubin < 2 mg/dL
- •Life expectancy of at least 3 months
- •Written informed consent
- •Optimal harvest of autologous stem cells (CD34+ cells > 5 million/kg plus 2 million/kg for back-up)
排除标准
- •Prior hematopoietic stem cell transplantation
- •Prior RIT
- •Prior external radiation to > 25% of active bone marrow
- •CNS involvement of non-Hodgkin's lymphoma
- •Serious comorbid diseases
- •HIV or HTLV-1 associated malignancy
- •History of other malignant disease in the previous 5 years, except squamous cell or basal cell carcinoma of skin or stage I uterine cervical carcinoma or cervical carcinoma in situ
- •Known hypersensitivity to murine antibodies/proteins
- •Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT
- •Persistent toxic side effects from prior therapy
- •Prior biologic or immunotherapy less than 4 weeks prior to entry on this study
- •Investigational drugs less than 4 weeks prior to entry on this study
研究组 & 干预措施
Zevalin-BuCyE
histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.
干预措施: Zevalin-BuCyE (Drug)
结局指标
主要结局
Event-free survival
时间窗: the time from stem cell infusion to failure or death from any cause
Three year event-free survival rate would be reported.
次要结局
- Overall survival(from stem cell infusion to death of any cause or last follow-up)
- Toxicity of the treatment combination(any toxicity due to study treatment during study period)
研究者
Cheolwon Suh
ASCT team
Asan Medical Center