Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Disease Recurrence
研究概览
简要总结
Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In case there is evidence of disease recurrence on highly sensitive molecular assays, their drug therapy is restarted. The study aims to identify proportion of patients who can be kept off drug therapy in a state of sustained molecular remission.
详细描述
While a large number of studies which have stopped TKI therapy in similar patients exist in Europe and USA, no such study has been done on Indian or other south Asian population. Almost all studies done previously have noted that in relapsed patients, who show disease recurrence on stopping their TKI therapy, their remission state is regained once the TKI therapy is restarted.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of CML on TKI (Imatinib) therapy for more than 5 years
- •Patients who have been in complete molecular response (MR 4.5 +) for at least three years
排除标准
- •Patients who ever had blast crisis
- •Patients achieving molecular response with second generation TKI due to failure of Imatinib
研究组 & 干预措施
Sustained molecular remission
Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy
干预措施: Stopping the standard drug therpy (Other)
Sustained molecular remission
Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy
干预措施: Quantitative bcrabl recording every month for first 6 months (Diagnostic Test)
结局指标
主要结局
Disease Recurrence
时间窗: 12 months from cessation of the drug therapy
Re-appearance of bcr-abl transcripts by RQPCR at a level \>0.01%
次要结局
未报告次要终点
研究者
Sanjeevan Sharma
Clinical Hematologist
Command Hospital, India