Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 848
- 试验地点
- 3
- 主要终点
- Event free survival
研究概览
简要总结
This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment
详细描述
Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89 therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both reduction and deletion. Randomization occurs following COPADM1 and is stratified for national group, histology (large cell; small non cleaved cell) and stage (Murphy I orII; Murphy III+LDH<2N; Murphy III+LDH>2N or Murphy IV).
The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS
Group C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE + deletion of the last 3 maintenance courses. Randomization occurs following COPADM2 and is stratified for national group, histology (large cell; small non cleaved cell) and CNS disease.
The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C
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
- 6 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed B lineage non-Hodgkin's lymphoma with Revised European American Lymphoma (REAL) II 9 (diffuse large cell lymphoma), 10 (Burkitt's lymphoma), or 11 (high grade B cell lymphoma, Burkitt's like) or bone marrow > 5% L3 blasts.
- •Pre treatment imaging studies adequate to document Murphy disease stage
- •Group B and C patients are eligible for randomization (Therapy stratification by group : Group A=completely resected stage I or completely resected abdominal stage II lesions, Group B= All cases not eligible for Group A or Group C, Group C= Any CNS involvement and/or bone marrow involvement ³ 25% blasts)
- •Patients should be available for a minimum follow up of 36 months
- •Informed consent prior to study entry
排除标准
- •Anaplastic large cell Ki 1 positive lymphomas
- •Previous chemotherapy.
- •Congenital immunodeficiency
- •Prior organ transplantation
- •Previous malignancy of any type
- •Known HIV positivity
研究组 & 干预措施
LMB C standard
干预措施: LMB C (Drug)
LMB C with mini CYVE and without 3 maintenance courses
干预措施: mini CYVE, without 3 maintenance courses (Drug)
Standard LMB B
干预措施: LMB B (Drug)
LMB B without COPADM3
干预措施: without COPADM3 (Drug)
LMB B with half cyclophosphamide
干预措施: half cyclophosphamide (Drug)
LMB B without COPADM3 and with half cyclophosphamide
干预措施: half cyclophosphamide (Drug)
LMB B without COPADM3 and with half cyclophosphamide
干预措施: without COPADM3 (Drug)
结局指标
主要结局
Event free survival
时间窗: 3 years
Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)
次要结局
- Survival(3 years)
- long term toxicity(10 years)