Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- composite complete remission (CR) rate
研究概览
简要总结
In this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T(8;21)acute myeloid leukemia patients with KIT D816 mutation diagnosed by bone marrow morphology, immunology, molecular genetics. The diagnosis and classification are according to WHO 2016 criteria.
- •Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible.
- •Age is not limited. Both male and female are eligible.
- •Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point.
- •Informed consent form must be signed by patients themselves before enrolled for patients aged 18 years or older. Informed consent form must be signed by the legal guardian for patients younger than 18 years.
排除标准
- •Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable.
- •Isolated extramedullary relapsed leukemia.
- •With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.
研究组 & 干预措施
Dasatinib plus chemotherapy
Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation
干预措施: Dasatinib (Drug)
结局指标
主要结局
composite complete remission (CR) rate
时间窗: 8 weeks
confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)
次要结局
- mortality during induction chemotherapy(30 days)
- post relapsed overall survival(2 years)
- overall survival(5 years)
- post relapsed disease free survival(2 years)