Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.
详细描述
We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.
Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed marginal zone B-cell lymphoma
- •Performance status (ECOG) ≤3
- •At least one or more bidimensionally measurable lesion(s):
- •2 cm by conventional CT
- •1 cm by spiral CT
- •skin lesion (photographs should be taken)
- •measurable lesion by physical examination
- •Laboratory values:
- •Cr < 2.0 mg% or Ccr > 60 ml/min
- •Transaminase < 3 X upper normal value
- •Bilirubin < 2 mg%
- •ANC > 1500/ul, platelet > 75,000/ul
- •Informed consent
- •Ann Arbor stage III or IV
排除标准
- •Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
- •Serious comorbid diseases
- •Pregnancy or breast feeding
研究组 & 干预措施
Gemcitabine
- histologically confirmed marginal zone lymphoma
- gemcitabine 1,250 mg/m2 on days 1 and 8 of each cycle, repeated every 3 weeks and continued for 6 cycles, until disease progression, withdrawal due to toxicity, or withdrawal of consent.
干预措施: gemcitabine (Drug)
结局指标
主要结局
response rate
时间窗: CR+PR with study therapy
次要结局
- safety and tolerability of the treatment(toxicity due to stdy drug)
研究者
Cheolwon Suh
ASCT team
Asan Medical Center