Effect of Prophylactic TKI Therapy Post-transplants on Ph+ ALL Undergoing Allo-HSCT With MRD Positive Pre-transplants
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Nanfang Hospital of Southern Medical University
Collaborators:
Guangzhou First People's Hospital Peking University People's Hospital Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Third Affiliated Hospital, Sun Yat-Sen University Zhujiang Hospital