effect of prophylactic tki therapy post-transplants on ph+ all undergoing allo-hsct with mrd positive pre-transplants

Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia; Tyrosine Kinase Inhibitor; Minimal Residual Disease; Allogeneic Hematopoietic Stem Cell Transplantation

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.

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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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)