Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT (Case-Only)

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

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 Overview

• Status: Withdrawn
• Conditions: Prophylactic HQP1351 Therapy; Third Generation TKI
• Intervention / Treatment: Drug: HQP1351( Olverembatinib dimesylate)

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: na xu; Phone Number: 02062787883; Email: 292347668@qq.com
• Study Contact Backup: Name: na xu; Phone Number: 292347668@qq.com

Study Locations

• China
  • Guanzhou, China
    • Department of Hematology, Nanfang Hospital, Southern Medical University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: xuna
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: October 30, 2022
• First Submitted That Met QC Criteria: October 30, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: CML; HQP1351; Prophylactic therapy; ph+ ALL
• Other Study ID Numbers: PH20221030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No