Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Disease Free Survival（DFS）
研究概览
简要总结
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ luekemia. In this study, we will evaluate the safety and efficacy of newly third TKI-HQP1351 therapy post-transplants on Ph+ leukemia after allo-HSCT with MRD positive pre-transplants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age of 18-65 years
- •Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants
- •Survival > 30 days post-transplants
- •Laboratory parameters as defined below:
- •Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD),Total bilirubin less than or equal to 3 x ULN
- •Ability to understand and willingness to sign a written informed consent form
排除标准
- •Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
- •Survival <30 days post-transplants
- •MRD positive on day +30 post-transplants
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (investigators' decision)
研究组 & 干预措施
HQP1351 prophylactic therapy
HQP1351 prophylactic therapy after allo-hct on days 30 to 60
干预措施: HQP1351( Olverembatinib dimesylate) (Drug)
结局指标
主要结局
Disease Free Survival（DFS）
时间窗: 2 years
The time from the date of transplantation to leukemia relapse
次要结局
- Overall survival(OS)(2 years)
- Adverse effects of TKI therapy(2 years)
- Relapse rate(2 years)
研究者
xuna
professor
Nanfang Hospital, Southern Medical University