Phase III Study Treatment of CLL B and C
2007年10月31日 更新者:French Innovative Leukemia Organisation
A Multicentric Phase III Study in Patients With CLL B and C < 60 Years Not Treated: 6 Montly CHOP + 6 CHOP Every 3 Months Versus 3 Montly CHOP + Intensification and Autograft
GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C Binet stages B-CLL and on an intent to treat basis two strategies.
Conventional chemotherapy consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in case of response.
Experimental arm consisted of high dose therapy with autologous CD34+ purified progenitor cell support, used as consolidation of Complete Remission or Very Good Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses of fludarabine in case of insufficient response.
研究概览
详细说明
The aim of the prospective randomized GOELAMS LLC 98 trial reported here was to compare two therapeutic strategies in previously untreated B and C Binet stages B-CLL patients less than 60 years old.
Conventional chemotherapy (Arm A) consisted of six monthly courses of CHOP, i.e. vincristin IV 1 mg/m2 on day 1, doxorubicin IV 25 mg/m2 on day 1, cyclophosphamide (Cy) 300 mg/m2 and prednisone 40 mg/m2 both given orally from day 1 to day 5, followed by 6 CHOP courses every other 3 months in case of response.
Fludarabine (25 mg/m2 /d IV for 5 consecutive days) was used in case of non response (stable disease or progression) after 3 CHOP courses.
This conventional therapy was compared to high dose therapy with autologous CD34+ purified progenitor cell support (Arm B), used as consolidation of Complete Remission (CR) or Very Good Partial Response (VGPR, defined by >50 % tumoral response and bone marrow lymphocyte infiltration <30%) obtained after 3 monthly courses of CHOP.
In the absence of CR or VGPR, 3 to 6 monthly-courses of fludarabine were performed before mobilization with Cy 4 g/m2 + G-CSF administration.
The conditioning regimen included TBI 12 Gy and Cy 60 mg /kg /d for 2 days.
研究类型
介入性
注册 (实际的)
140
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- CLL with Lymphocitis > 15.10 9/L
- B-CLL stage B or C
- Patients > 18 years old and < 60 years old
- No previous treatment of CLL
- ECOG performance status < 2
- Good cardiac function
- Patient's written informed consent
Exclusion Criteria:
- B-CLL stage A
- Age > 60 years old
- previous treatment of CLL
- ECOG performance status > 2
- Cardiac or pneumo Insufficency
- hepatic or renal Insufficency
- Seropositivity HIV
- Previous other malignancy
- Fertile male and female patients who cannot or do not wish to use an effective method of contraception
- Any coexisting medical or psychological condition that would preclude participation to the required study procedures
- NOt signed Patient's informed consent
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:A
¨Chemotherapy by 12 courses of CHOP
|
|
有源比较器:B
¨Chemotherapy by 3 courses of CHOP, intensification and autograft
|
Treatment by Intensive Chemotherapy and autograft
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
progression free survival
大体时间:Overal survival
|
Overal survival
|
次要结果测量
结果测量 |
大体时间 |
---|---|
response belong NIC criterias
大体时间:3 years after the end of treatment
|
3 years after the end of treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Annie BRION, RN、French Innovative Leukemia Organisation
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
1999年1月1日
研究完成 (实际的)
2006年3月1日
研究注册日期
首次提交
2007年9月26日
首先提交符合 QC 标准的
2007年9月26日
首次发布 (估计)
2007年9月27日
研究记录更新
最后更新发布 (估计)
2007年11月1日
上次提交的符合 QC 标准的更新
2007年10月31日
最后验证
2007年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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