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临床试验/NCT03624530
NCT03624530Unknown2 期

Effect of Prophylactic Tyrosine Kinase Inhibitor Therapy Post-transplants on Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Undergoing Allo-HSCT With Minimal Residual Disease Positive Pre-transplants

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
82
试验地点
1
主要终点
Overall survival(OS)

研究概览

简要总结

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) in early first complete remission improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). 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. Our previous clinical trial (ID: NCT01883219) demonstrated that 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+ ALL. Moreover, our result suggested that Ph+ ALL with MRD positive pre-transplants had the higher rate of molecular biology relapse. In this study, we will evaluate the safety and efficacy of prophylactic TKI therapy post-transplants on Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants.

详细描述

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) in early first complete remission improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Relapse remains a major cause of treatment failure even after allo-HSCT. Overall, patients experiencing relapse have a dismal prognosis despite salvage treatment with TKIs. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Strategies to prevent relapse include tyrosine kinase inhibitor (TKIs) use, donor lymphocyte infusions (DLI), CAR-T and so on. At present, the utility of TKIs administration post-transplants is controversial. Our previous clinical trial (ID: NCT01883219) demonstrated that pre-emptive TKI 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+ ALL. Moreover, we found that 58% Ph+ ALL with MRD positive pre-transplants would MRD positive post-transplants, whereas only 11.4% Ph+ ALL with MRD negative pre-transplants would MRD positive post-transplants, suggesting that Ph+ ALL with MRD positive pre-transplants had the higher rate of molecular biology relapse. In this study, we will evaluate the safety and efficacy of prophylactic TKI therapy post-transplants on Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age of 14-65 years
  • Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants
  • Survival > 30 days post-transplants
  • MRD negative on day +30 post-transplants

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

Prophylactic TKI Therapy

Experimental

Treatment with prophylactic TKI will be initiated from day +30 to +60 post-transplants. TKI was selected according to the mutation results of ABL kinase region.

干预措施: Tyrosine kinase inhibitor (TKIs) (Drug)

结局指标

主要结局

Overall survival(OS)

时间窗: 2 year

the time from the date of transplantation to death or the last day of follow-up

次要结局

  • Relapse rate(2 year)
  • Disease-free survival(DFS)(2 year)
  • Adverse effects of TKI therapy(2 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qifa Liu

Professor

Nanfang Hospital, Southern Medical University

研究点 (1)

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