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

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Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Prophylactic HQP1351 Therapy Third Generation TKI

Interventions

HQP1351( Olverembatinib dimesylate)DRUG

HQP1351 was initiated at a dose of 40mg every two days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient age of 18-65 years 2. Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants 3. Survival \> 30 days post-transplants 4. 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 5. Ability to understand and willingness to sign a written informed consent form Exclusion Criteria: 1. Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants 2. Survival \<30 days post-transplants 3. MRD positive on day +30 post-transplants 4. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) 5. Patients with any conditions not suitable for the trial (investigators' decision)

Locations (1)

Department of Hematology, Nanfang Hospital, Southern Medical University,

Guanzhou, China

Outcomes

Primary Outcomes

Disease Free Survival（DFS）

The time from the date of transplantation to leukemia relapse

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2 years

Relapse rate

the cumulative relapse rate of leukemia

Time frame: 2 years

Adverse effects of TKI therapy

Number of participants with treatment-related adverse events

Time frame: 2 years

Data from ClinicalTrials.gov

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