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

Phase 2

Withdrawn

• Conditions: Prophylactic HQP1351 Therapy; Third Generation TKI
• Interventions: Drug: HQP1351( Olverembatinib dimesylate)

• Registration Number: NCT05604755
• Lead Sponsor: xuna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-10-30
• Study First Posted: 2022-11-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HQP1351 prophylactic therapy	HQP1351( Olverembatinib dimesylate)	HQP1351 prophylactic therapy after allo-hct on days 30 to 60

Primary Outcome Measures

Name	Time	Method
Disease Free Survival（DFS）	2 years	The time from the date of transplantation to leukemia relapse

Secondary Outcome Measures

Name	Time	Method
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
Adverse effects of TKI therapy	2 years	Number of participants with treatment-related adverse events
Relapse rate	2 years	the cumulative relapse rate of leukemia

Trial Locations

Locations (1)

Department of Hematology, Nanfang Hospital, Southern Medical University,; 🇨🇳 Guanzhou, China