NCT00478985已完成不适用
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
University Hospital, Bordeaux48 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 48
- 主要终点
- Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts
研究概览
简要总结
The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.
详细描述
Principal Objective : To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia .
Secondary Objective :
- To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia.
- To determine the biologics factors (immunologic and molecular) associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia.
- To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib.
- To determine the complete molecular remission length.
- To evaluate medical and economical impact of stopping imatinib treatment.
Study design : multicentric trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have reached their 18th birthday
- •Women of childbearing potential must agree to use effective methods of contraception
- •Patients must be affiliated to a social security regime
- •Patients must have received imatinib therapy for at least 36 months.
- •Patients must be in complete molecular remission during at least two consecutive years with at least five RT-PCR negative measures for bcr-abl transcripts.
- •Patients must be HIV, HCV and HBV negatives
- •Patients who have molecular follow-up realized in accordance with international recommendations
- •All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
排除标准
- •Patients who are protected by the law. Patients who are unable to give their consent to participate to the study.
- •Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. Patients who have pathologies or treatments which able to interfere with immunologic study (excepted IFN α):
- •Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe
结局指标
主要结局
Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts
时间窗: Every month during the first year and every two months during the second year
次要结局
- T lymphocytes differenciation and proliferation analyse / cytokines production analyse(first visit, M2,M4,M6,M9,M12,M18,M24)
- T lymphocytes apoptosis analyse(first visit)
- Haemogramme analyse(every months during two years)
- Clinical exam(every three months during the first year and every four months during the second year)
研究者
研究点 (48)
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