NCT00265928终止2 期
VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, including Waldenstrom's macroglobulinemia.
详细描述
OBJECTIVES:
Primary
- Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory, B-cell non-Hodgkin's lymphoma.
- Determine the overall response rate (partial response, complete response unconfirmed, and complete response) in these patients.
Secondary
- Estimate the duration of response in patients treated with this regimen.
- Estimate the time to disease progression in patients treated with this regimen.
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 B-cell non-Hodgkin's lymphoma (NHL) including the following subtypes:
- •B-cell small lymphocytic lymphoma
- •Marginal zone lymphoma (extranodal, nodal, or splenic)
- •Grade 1-3 follicular lymphoma
- •Mantle cell lymphoma
- •Waldenstrom's macroglobulinemia
- •Bidimensionally measurable disease by CT scan with ≥ 1 lesion measuring > 1.5 cm in a single dimension
- •Relapsed or refractory disease after prior antineoplastic therapy, meeting 1 of the following criteria:
- •No response to prior treatment
- •Relapsed disease after prior therapy
- •Confirmed CD20-positive disease by immunohistochemistry on biopsy specimen
- •Prior transformation allowed provided there is no evidence of aggressive histology on recent biopsy
- •No chronic lymphocytic lymphoma with absolute lymphocyte count > 5,000/mm³
- •No CNS involvement
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3 (≥ 1,000/mm³ if due to extensive bone marrow involvement with NHL or splenomegaly)
- •Absolute lymphocyte count ≤ 5,000/mm³ (except mantle cell lymphoma with a leukemic phase)
- •Platelet count ≥ 50,000/mm^3
- •Bilirubin ≤ 2.0 mg/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN) (4 times ULN if liver involvement with NHL)
- •Creatinine ≤ 2.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile male and female patients must use effective contraception during study
- •No serious nonmalignant disease
- •No active infection
- •No peripheral neuropathy ≥ grade 2 within past 14 days
- •No myocardial infarction within the past 6 months
- •No New York Heart Association class III or IV heart failure
- •No uncontrolled angina pectoris
- •No severe uncontrolled ventricular arrhythmias
- •No EKG evidence of acute ischemia or active conduction system abnormalities
- •Any EKG abnormality must be documented as not medically relevant
- •No hypersensitivity to bortezomib, boron, or mannitol
- •No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins or any component of rituximab (including polysorbate 80 and sodium citrate dehydrate)
- •No known infection or exposure to HIV
- •No serious psychiatric or medical illness that would preclude study participation
- •No active hepatitis B infection
- •No other primary malignancy requiring active treatment
- •More than 4 weeks since prior significant traumatic injury
- •PRIOR CONCURRENT THERAPY:
- •At least 3 weeks since prior and no concurrent radiotherapy
- •More than 4 weeks since prior major surgery or open biopsy
- •Other diagnostic surgery allowed
- •More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
- •At least 3 months since prior unconjugated monoclonal antibody therapy
- •At least 10 weeks since prior radioimmunoconjugates or toxin immunoconjugates (e.g., iodine I 131 tositumomab [Bexxar] or ibritumomab tiuxetan [Zevalin])
- •More than 2 weeks since prior investigational agent
- 另有 7 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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