A Prospective Study on Early Conversion of Dasatinib in CML-CP Patients Who Have Not Early Molecular Response on Imatinib
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MMR in 1 year
研究概览
简要总结
Chronic myeloid leukemia (CML) is a malignant disease of acquired hematopoietic stem cells. The BCR-ABL fusion gene is the pathogenic basis of CML. Tyrosine kinase inhibitors (TKIs) are targeted drugs for this fusion protein. With the wide clinical application of TKIs, the efficacy of CML patients has been greatly improved. However, there are still a significant number of patients who have poor response to the first generation of TKI drugs, imatinib, most of them have early molecular response failures (BCR-ABL（IS）>10% at 3 or 6 months) ，which means lower rates of molecular response, increased risk of progression, and higher overall survival. For them, the early conversion of dasatinib might be a better choice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-65 years old； 2.CML-CP,and Imatinib treatment longest for 6 months ； 3.Q-pcr monitoring of BCR/ABLIS failed to achieve the best therapeutic effect（BCR/ABLIS>10.00% in 3m or BCR/ABLIS>1.00% in 6m）； 4.No previous history of malignant tumor; 5.Informed consent of the patient or his legal representative
排除标准
- •History of CML-CP or CML-AP;
- •Resistant to dasatinib,or treatment with imatinib more than 6 months;
- •Received allogeneic hematopoietic stem cell transplantation,or immunotherapy;
- •woman who is pregnant or nursing
- •Combined with other serious organic diseases, serious arrhythmia, pulmonary hypertension, cardiomyopathy, serious autoimmune diseases.
研究组 & 干预措施
Dasatinib group
干预措施: Dasatinib 100 MG (Drug)
Imatinib group
干预措施: Dasatinib 100 MG (Drug)
结局指标
主要结局
MMR in 1 year
时间窗: 1 year
MMR(BCR/ABL(IS)\<0.1%) at 12 months after switching to dasatinib for patients who did not achieve optimal treatment with imatinib for 3 to 6 months.
次要结局
未报告次要终点
研究者
xuna
Associate chief physician
Nanfang Hospital, Southern Medical University