The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib
研究概览
简要总结
The aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy drugs, lower the side effect brought by which this would be a grateful news for the patients once this regimens gain a successful result, which is also the final aim of our efforts.
详细描述
The investigators new therapy regimens: The investigators use dexamethasone 10mg/d(d3-d7) as pre-processing therapy, dasatinib 100mg (d1-d84) plus prednisone 60mg/m2 (d1-24), reduce to d32, as inductive treatment after inductive treatment, if the patient get major molecular remission, patient will get to consolidation therapy, that is methotrexate (MTX) 3g/m2 d1, if not, this patient would be excluded from our trail. after consolidation therapy, if the patient have matched bone marrow donor, the investigators will suggest the patient receipting allogens-stem cell transplantation, otherwise, autogens stem cell transplantation can also be considered once the patient have no applicable bone marrow donor. on the other side, if the patient still not get MMR after this two cycle, maybe the patient can try Car-T, or other chemotherapy regimens.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Get signed the informed consent of patients and family members
- •Age ≥ 18 one full year of life
- •Confirm the ph + ALL at molecular biology level
- •Normal heart and lungs function
- •Normal liver and kidney function
排除标准
- •Leukemia in the nervous system
- •Recurrent patients
- •Allergies associated with any drug in our research
- •At the same time with other organs' malignant tumours
- •participating in other clinical researches at the same time
研究组 & 干预措施
ph+ ALL with dasatinib
patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy.
干预措施: Dasatinib (Drug)
ph+ ALL with dasatinib
patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy.
干预措施: prednisone (Drug)
ph+ ALL with dasatinib
patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy.
干预措施: dexamethasone (Drug)
ph+ ALL with dasatinib
patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy.
干预措施: methotrexate (Drug)
结局指标
主要结局
The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib
时间窗: 115 days
次要结局
- Time needed to achieve MMR(30 days)