NCT00089115终止3 期
Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma
Favrille118 个研究点 分布在 1 个国家开始时间: 2004年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 试验地点
- 118
- 主要终点
- Time to progression after 248 patients have progressed
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells.
PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF) with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.
Secondary
- Compare response rate improvement in patients treated with these regimens.
- Compare overall complete response rate in patients treated with these regimens.
- Compare duration of response in patients treated with these regimens.
- Determine the safety of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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 follicular B-cell non-Hodgkin's lymphoma (NHL)
- •Grade 1, 2, or 3
- •Meets 1 of the following criteria for treatment with rituximab:
- •Treatment naïve
- •Relapsed or refractory disease after prior chemotherapy
- •Relapsed after a prior documented response (i.e., complete or partial response) to rituximab of at least 6 months duration
- •Tumor accessible for biopsy OR existing biopsy material (taken within the past 6 months) suitable for vaccine preparation
- •Measurable or evaluable disease after tumor tissue procurement for vaccine production
- •No more than 2 prior treatment regimens for NHL
- •Single regimens include any of the following:
- •Maintenance rituximab
- •Rituximab administered once weekly for 8 courses
- •Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab* NOTE: *CHOP followed by rituximab at time of relapse is considered 2 treatment regimens
- •No history of CNS lymphoma or meningeal lymphomatosis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 75,000/mm^3 (unless related to bone marrow involvement by lymphoma)
- •Hemoglobin ≥ 10g/dL
- •Not specified
- •Not specified
- •Cardiovascular
- •No congestive heart failure
- •No compromised pulmonary function
- •Immunologic
- •HIV negative
- •No prior allergic response to GM-CSF
- •No active bacterial, viral, or fungal infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychiatric disorder that would preclude study participation
- •No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other serious nonmalignant disease that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •See Chemotherapy
- •At least 4 weeks since prior immunotherapy
- •No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or ibritumomab tiuxetan)
- •No prior autologous or allogeneic stem cell transplantation
- •No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)
- •No prior investigational vaccine or immunotherapeutic containing keyhole limpet hemocyanin (KLH)
- •Chemotherapy
- •See Disease Characteristics
- 另有 13 项未显示
排除标准
- 未提供
结局指标
主要结局
Time to progression after 248 patients have progressed
次要结局
- Response rate improvement after 248 patients have progressed
- Overall complete response rate by modified Cheson Criteria after 248 patients have progressed
- Duration of response by modified Cheson Criteria after 248 patients have progressed
- Safety by Common Toxicity Criteria (CTC) after 248 patients have progressed
研究者
研究点 (118)
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