A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90 ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine 12-week overall and complete response rate in patients with indolent non-Hodgkin's lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as first-line treatment.
Secondary
- Determine 1-year event-free survival of patients treated with this regimen.
- Determine time to progression and time to next antilymphoma therapy in patients treated with this regimen.
- Determine the molecular response rate in patients treated with this regimen.
- Determine the hematological and non-hematological toxicity of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the following histologic subtypes:
- •Grade1 or 2 follicular lymphoma
- •Small lymphocytic lymphoma (SLL)
- •Marginal zone B-cell lymphoma
- •CD20-positive disease confirmed by immunohistochemistry or flow cytometry
- •Bidimensionally measurable disease
- •At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan
- •Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone marrow aspiration and biopsy within the past 6 weeks
- •No clinically significant impaired bone marrow reserve as evidenced by any of the following:
- •Hypocellular marrow, as evidenced by 1 of the following:
- •≤ 15% cellularity
- •Marked reduction in bone marrow precursors
- •Platelet count < 100,000/mm^3
- •Absolute neutrophil count < 1,500/mm^3
- •History of failed stem cell collection
- •Prior myeloablative therapy
- •No greater than 5,000/mm^3 circulating tumor cells in peripheral blood
- •Requires antilymphoma therapy, as indicated by any of the following:
- •Systemic symptoms
- •B symptoms
- •Cytopenias
- •Organ compromise
- •Discomfort
- •Disfigurement
- •Rapidly progressive disease
- •Undue anxiety related to not receiving treatment
- •No transformation to intermediate or high-grade NHL
- •No known brain metastases or CNS involvement by lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •WHO 0-2 OR
- •Karnofsky 70-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •See Disease Characteristics
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Lymphocyte count < 5,000/mm^3 (for patients with SLL )
- •Bilirubin ≤ 2.0 mg/dL
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine ≤ 2.0 mg/dL OR
- •Creatinine clearance > 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- 另有 27 项未显示
排除标准
- 未提供
研究组 & 干预措施
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
干预措施: yttrium Y 90 ibritumomab tiuxetan (Radiation)
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
干预措施: rituximab (Biological)
结局指标
主要结局
Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks
时间窗: 14 weeks
INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.
EFS
时间窗: 1 year
Event = Death, second malignancy , disease progression.
次要结局
未报告次要终点
研究者
Robin Joyce
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center