Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- tumor response
研究概览
简要总结
The goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy.
Participants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.
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
- •Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)
- •Age ≥ 18 years
- •VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration
- •Signed informed consent form
- •Affiliation to a social security system, or beneficiary of such a system
排除标准
- •Patient eligible to a targeted therapy having a market authorization
- •Central nervous system involvement
- •Heart failure
- •Liver failure
- •Kidney failure
- •Contraindication to DASATINIB
- •Positive for HIV (detectable viral load), Hepatitis B or C
- •Pregnant or breastfeeding woman
- •No efficient contraception for the women of childbearing age
- •Emergency situation person or not able to express his/her informed consent
- •Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)
- •Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons
研究组 & 干预措施
DASATINIB
干预措施: Dasatinib (Drug)
结局指标
主要结局
tumor response
时间窗: 2 months
Objective response rate after 2 cycles of 28 days DASATINIB defined as the rate of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) according to ELN 2022 criteria.
次要结局
- response rates(3 months)
- Time to response(3 months)
- Duration of relapse-free period(3 months)
- Event-free survival(3 months)
- Overall survival(3 months)
- Occurrence of Adverse Events(3 months)