Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 454
- 试验地点
- 74
- 主要终点
- Event-free-survival (EFS)
研究概览
简要总结
Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.
In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
- •any stage (Ann Arbor I-IV)
- •either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
- •no evidence of histologic transformation to a high grade lymphoma
- •measurable or evaluable disease
- •life expectancy of at least 1 year
- •ECOG performance status 0-2
- •no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
- •no prior chemotherapy
- •no prior immunotherapy with any anti-CD20 monoclonal antibody
- •no prior radiotherapy in the last 6 weeks
- •no corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
- •no evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
- •no evidence of symptomatic central nervous system (CNS) disease
- •no impairment of bone marrow function (WBC >3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement
- •no major impairment of renal function (serum creatinine <1,5x upper normal) or liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement
- •no evidence of active opportunistic infections
- •no known HIV infection
- •no active HBV and/or HCV infection
- •no pregnant or lactating status
- •appropriate contraceptive method in women of childbearing potential or men
- •absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •informed consent must be given according to national/local regulations before randomization
排除标准
- 未提供
研究组 & 干预措施
ARM A
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
干预措施: chlorambucil (drug) (Drug)
ARM B
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
干预措施: rituximab+chlorambucil (Drug)
ARM C (Since April 2006)
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
干预措施: rituximab (Drug)
结局指标
主要结局
Event-free-survival (EFS)
时间窗: 5 years
Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration
次要结局
- Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment(End of treatment (after 24 weeks of therapy))
- Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration(5 years)
- Progression-free-survival (PFS)(5 years)
- Overall Survival(5 years)