Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma
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.
研究概览
详细说明
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.
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV followed, no more than 4 hours later, by indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day 1. If biodistribution is acceptable, patients receive rituximab IV followed, no more than 4 hours later, by a single dose of yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, or 9 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, weeks 6, 10, and 14, every 3 months for 2 years, and then every 6 months for 2 years.
After completion of study treatment, patients are followed weekly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 18-28 patients will be accrued for this study within 2 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
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New Hampshire
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Lebanon、New Hampshire、美国、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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Vermont
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Burlington、Vermont、美国、05401-3498
- Vermont Cancer Center at University of Vermont
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
- Malaise
- Organ compromise
- Discomfort
- Pain
- 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:
Age
- Over 18
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 )
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
Renal
- Creatinine ≤ 2.0 mg/dL OR
- Creatinine clearance > 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Immunologic
- No anti-murine antibody reactivity (in patients with prior exposure to murine antibodies or proteins)
- No ongoing or active infection
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to yttrium Y 90 ibritumomab tiuxetan
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 1 year after study treatment
- No other active malignancy except non-melanoma skin cancer
- No other serious nonmalignant disease that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior pegfilgrastim
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional)
Surgery
- More than 4 weeks since prior major surgery except diagnostic surgery
Other
- No prior systemic antilymphoma therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No other concurrent antilymphoma therapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks
大体时间: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. |
14 weeks
|
EFS
大体时间:1 year
|
Event = Death, second malignancy , disease progression.
|
1 year
|
合作者和调查者
调查人员
- 学习椅:Robin Joyce, MD、Beth Israel Deaconess Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- III 期 1 级滤泡性淋巴瘤
- III期2级滤泡性淋巴瘤
- IV 期 1 级滤泡性淋巴瘤
- IV 期 2 级滤泡性淋巴瘤
- I 期 1 级滤泡性淋巴瘤
- I 期 2 级滤泡性淋巴瘤
- 连续 II 期 1 级滤泡性淋巴瘤
- 连续 II 期 2 级滤泡性淋巴瘤
- 非连续性 II 期 1 级滤泡性淋巴瘤
- 非连续性 II 期 2 级滤泡性淋巴瘤
- 非连续性 II 期小淋巴细胞淋巴瘤
- 非连续性 II 期边缘区淋巴瘤
- I期边缘区淋巴瘤
- I期小淋巴细胞淋巴瘤
- III期小淋巴细胞淋巴瘤
- III期边缘区淋巴瘤
- IV期小淋巴细胞淋巴瘤
- IV期边缘区淋巴瘤
- 连续II期边缘区淋巴瘤
- 相邻的 II 期小淋巴细胞淋巴瘤
- 黏膜相关淋巴组织结外边缘区B细胞淋巴瘤
- 淋巴结边缘区B细胞淋巴瘤
- 脾边缘区淋巴瘤
其他相关的 MeSH 术语
其他研究编号
- 2004P000044
- CDR0000409723 (注册表标识符:PDQ (Physician Data Query))
- NCI-2011-02445 (注册表标识符:CTRP (Clinical Trials Reporting System))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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