Prophylactic HQP1351 Therapy, Third Generation TKI
Conditions
Keywords
CML, ph+ ALL, HQP1351, Prophylactic therapy
Brief 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.
Interventions
DRUGHQP1351( Olverembatinib dimesylate)
HQP1351 was initiated at a dose of 40mg every two days
Sponsors
Nanfang Hospital, Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Guangdong Second Provincial General Hospital
xuna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival（DFS） | 2 years | The time from the date of transplantation to leukemia relapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | 2 years | 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 |
| Relapse rate | 2 years | the cumulative relapse rate of leukemia |
| Adverse effects of TKI therapy | 2 years | Number of participants with treatment-related adverse events |
Countries
China
Outcome results
None listed