NCT00893477Unknown2 期
An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With Rituximab (MabThera®) in Patients With Follicular Non Hodgkin's Lymphoma With no Prior Treatment
French Innovative Leukemia Organisation0 个研究点目标入组 60 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- Overall objective tumor response rate at the end of induction therapy
研究概览
简要总结
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. 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 GM-CSF together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
详细描述
OBJECTIVES:
Primary
- Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of overall objective complete and partial response rates, in patients with previously untreated follicular non-Hodgkin lymphoma.
Secondary
- Evaluate the time to progression in patients treated with this regimen.
- Evaluate the overall survival of patients treated with this regimen.
- Evaluate the duration of response in patients treated with this regimen.
- Evaluate the safety profile of this regimen in these patients.
- Evaluate the influence of FcγR polymorphisms on clinical response.
- Monitor FcγR-expressing cells in peripheral blood during treatment.
- Monitor the molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification
- •Grade 1-3a disease
- •Stage II-IV disease
- •Non-bulky disease
- •Must have undergone initial nodal biopsy within the past 4 months
- •At least 1 measurable lesion
- •Low tumor-burden, as defined by the following GELF criteria:
- •Nodal or extranodal tumor mass (diameter < 7 cm)
- •No systemic B symptoms
- •No increased LDH and β2 microglobulinemia
- •No substantial splenic enlargement
- •No serous effusion
- •No compression syndrome
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active hepatitis
- •PRIOR CONCURRENT THERAPY:
- •No prior treatment, including steroids and radiotherapy
排除标准
- 未提供
结局指标
主要结局
Overall objective tumor response rate at the end of induction therapy
次要结局
- Time to progression
- Overall survival
- Duration of response
- Time to next treatment
- Safety profile
- Influence of FcγR polymorphisms on clinical response and survival
- FcγR expression during study treatment
- Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay
研究者
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