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NCT05604755
Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT
Conditions: Prophylactic HQP1351 Therapy, Third Generation TKI
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE2
Sponsor: xuna
Location: China
Summary
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.
Eligibility Criteria
Inclusion Criteria:Patient age of 18-65 yearsPh+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplantsSurvival > 30 days post-transplantsLaboratory 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 ULNAbility to understand and willingness to sign a written informed consent formExclusion Criteria:Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplantsSurvival <30 days post-transplantsMRD positive on day +30 post-transplantsAny 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)
Source: ClinicalTrials.gov (NCT05604755). StuddyBuddy aggregates publicly available trial information.