Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants

Conditions
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Prophylactic HQP1351 Therapy, Third Generation TKI

Intervention / Treatment
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* Drug: HQP1351( Olverembatinib dimesylate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HQP1351 prophylactic therapy<br>HQP1351 prophylactic therapy after allo-hct on days 30 to 60 | Drug: HQP1351( Olverembatinib dimesylate)<br>* HQP1351 was initiated at a dose of 40mg every two days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival（DFS） | The time from the date of transplantation to leukemia relapse | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) | the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up The time from the date of transplantation to death or the last day of follow-up | 2 years | 
| Relapse rate | the cumulative relapse rate of leukemia | 2 years | 
| Adverse effects of TKI therapy | Number of participants with treatment-related adverse events | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, ph+ ALL, HQP1351, Prophylactic therapy