NCT00073931已完成2 期
A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Disease-free survival measured continuously
研究概览
简要总结
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity and tolerability of this regimen in these patients.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-Hodgkin's lymphoma
- •CD20+ disease
- •Failed at least 1 prior standard systemic therapy
- •Persistent lymphoma by physical examination, radiographic studies, bone marrow evaluations, flow cytometry, or polymerase chain reaction
- •Tumor burden less than 500 cc by computed tomography or MRI
- •No splenomegaly
- •Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved
- •No circulating lymphoma cells by morphology or flow cytometry at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be used
- •10% or less marrow involvement by flow cytometry or morphology if purged bone marrow is to be used
- •No CNS lymphoma
- •No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated lymphocytic lymphoma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 60 days
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin less than 1.5 mg/dL
- •Creatinine less than 2.0 mg/dL
- •Cardiovascular
- •No active coronary artery disease
- •FEV_1 at least 70% of expected
- •Vital capacity at least 70% of expected
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •Able to perform self-care during radiation isolation
- •No major organ dysfunction
- •No major infection
- •No circulating anti-mouse antibody
- •No other serious medical condition considered to represent contraindications to bone marrow transplantation
- •No competing causes of death that would predict life span to be less than 10 additional years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior bone marrow or stem cell transplantation
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or more than 25% of red marrow)
- •Not specified
- •More than 30 days since prior systemic antilymphoma therapy
排除标准
- 未提供
结局指标
主要结局
Disease-free survival measured continuously
时间窗: from date of transplant through date of death
次要结局
未报告次要终点
研究者
研究点 (2)
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