NCT00070447已完成2 期
Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 87
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma.
详细描述
OBJECTIVES:
- Determine the time to treatment failure in patients with previously untreated mantle cell lymphoma treated with rituximab and CHOP chemotherapy comprising prednisone, cyclophosphamide, doxorubicin, and vincristine followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®).
- Determine the response rate in patients at the completion of rituximab and CHOP and the incremental response rate after IDEC-Y2B8.
- Determine the toxicity of this regimen in these patients.
- Correlate serum rituximab levels with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- CHOP chemotherapy and rituximab: Patients receive cyclophosphamide IV, doxorubicin IV, vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5 (R + CHOP). Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who have responding or stable disease proceed to radioimmunotherapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20
- •Stage II-IV disease
- •Measurable or evaluable disease
- •Measurable disease defined as at least 1 bidimensionally measurable lesion at least 2 cm by imaging scan
- •A spleen at least 17 cm or having discrete filling defects by CT scan will constitute evaluable disease provided that no explanation other than lymphomatous involvement (e.g., portal hypertension or other liver disease) is likely
- •No known CNS lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •WBC greater than 2,500/mm^3*
- •Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow
- •Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)
- •ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver involvement by lymphoma)
- •Creatinine less than 2.0 mg/dL
- •Calcium no greater than 11.5 mg/dL
- •Cardiovascular
- •LVEF greater than 45%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 year after study participation
- •HIV negative
- •No other malignancy except treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer or any other surgically cured malignancy from which the patient has been disease-free for at least 3 years
- •No other concurrent serious medical condition or active infection that would preclude ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and vincristine (CHOP) chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Prior corticosteroids allowed provided the course was no more than 2 weeks in duration
- •Radiotherapy
- •No prior radiotherapy
- •Not specified
排除标准
- 未提供
研究者
研究点 (87)
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