Case-Only: Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HQP1351 prophylactic therapy HQP1351 prophylactic therapy after allo-hct on days 30 to 60 |
Drug: HQP1351( Olverembatinib dimesylate)
HQP1351 was initiated at a dose of 40mg every two days
|
Outcome Measures
Primary Outcome Measures
- Disease Free Survival（DFS） [2 years]
The time from the date of transplantation to leukemia relapse
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Hematology, Nanfang Hospital, Southern Medical University, | Guanzhou | China |
Sponsors and Collaborators
- xuna
- Nanfang Hospital of 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PH20221030