Treatment-free remission in chronic myeloid leukemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- to determine the proportion of patients who will continue to remain in major molecular response (MMR) at 1 year (+/- 1 month) of discontinuation of imatinib.
研究概览
简要总结
Chronic myeloid leukemia (CML) is one of the common types of blood cancer. In the current era, the standard initial therapy for most of the patients with CML is a medicine called imatinib. It was previously thought that imatinib needs to be given life-long for patients with CML. However, several studies over the past decade have shown that, in a selected group of patients with CML, it is possible to discontinue imatinib and see if their disease continues to remain under control even without medicines. In scientific terms, this is known as treatment-free remission (TFR). In this study, we will be evaluating the outcomes of TFR in patients with CML.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient should be currently enrolled in the Max Access Solution (MAS) program of the Max Foundation.
- •(This program was previously known as the GIPAP (Global International Patient Access Program).
- •Under this program, enrolled patients are already receiving imatinib from the Max Foundation.) 2.Chronic phase CML (CML-CP) 3.On imatinib for more than 10 years 4.No history of imatinib resistance 5.RQ-PCR IS value less than 0.0032% for a minimum of 12 months (confirmed at least twice).
排除标准
- •1.Patients with accelerated phase or blast crisis at any point of time in the past 2.Patients not willing to sign the informed consent form /personal data notice.
结局指标
主要结局
to determine the proportion of patients who will continue to remain in major molecular response (MMR) at 1 year (+/- 1 month) of discontinuation of imatinib.
时间窗: 1 year
次要结局
- 1.To determine the kinetics of RQ-PCR for BCR-ABL in patients under TFR(2.To determine the incidence of “imatinib withdrawalâ€. (Imatinib withdrawal refers to a symptom complex which occurs due to sudden discontinuation of imatinib. The manifestations typically include bodyache, mild joint pains and occasionally low-grade fever).)
研究者
Dr Sachin Punatar
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre