Multicenter Clinical Study on the Safety and Efficacy of Nilotinib Discontinuation in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Complete Molecular Response - Stop Tasigna Trial (STAT2)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
We recruited 96 Japanese patients, of whom 78 sustained a deep molecular response during the consolidation phase and were therefore eligible to discontinue nilotinib in the treatment-free remission phase; of these, 53 patients (67.9%; 95% confidence interval: 56.4-78.1%) remained free from molecular recurrence in the first 12 months. The estimated 3-year treatment-free survival was 62.8%. Nilotinib was readministered to all patients (n=29) who experienced a molecular recurrence during the treatment-free remission phase. After restarting treatment, rapid deep molecular response returned in 25 patients (86.2%), with 50% of patients achiev- ing a deep molecular response within 3.5 months. Tyrosine kinase inhibitor withdrawal syndrome was reported in 11/78 patients during the early treatment-free remission phase. The treatment-free survival curve was significantly better in patients with undetectable molecular residual disease than in patients without (3-year treatment-free sur- vival, 75.6 versus 48.6%, respectively; P=0.0126 by the log-rank test). There were no significant differences in treatment-free survival between subgroups based on tyrosine kinase inhibitor treatment before the nilotinib consolidation phase, tyrosine kinase inhibitor- withdrawal syndrome, or absolute number of natural killer cells. The results of this study indicate that it is safe and feasible to stop tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia who have achieved a sustained deep molecular response with 2 years of treatment with nilotinib.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients who are participating in any other clinical trial. 2) Patients with the T315I point mutation of BCR-ABL. 3) Patients with a history of hematopoietic stem cell transplantation. 4) Patients with one of the following indicators of cardiovascular dysfunction. i) The QT interval cannot be measured on the ECG ii) Complete left bundle branch block iii) Ventricular pacemaker iv) Congenital QT interval prolongation syndrome or a family history of QT interval prolongation syndrome v) History of or current severe ventricular or atrial tachycardia vi) Clinically significant bradycardia at rest (<50 bpm) vii) History of clinically diagnosed myocardial infarction viii) History of unstable angina within 12 months prior to initiation of the study ix) Other clinically significant cardiovascular complications 5) Patients with another primary malignant tumor. 6) Gastrointestinal dysfunction or diseases that could greatly influence absorption of the study medication. 7) Patients with a history of acute or chronic pancreatitis within 1 year prior to participation to the study. 8) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period. 9) Patients with multiple invasive cancers within 5 years prior to initiation of the study. 10) Patients with other serious or uncontrollable complications. 11) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study. 12) Patients with cognitive dysfunction. 13) Other patients whom the investigator considers to be unsuitable for participation in the study.