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

NCT05604755 | Withdrawn Phase 2

• 1 other identifier: PH20221030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prophylactic HQP1351 Therapy; Third Generation TKI

Keywords

CML; ph+ ALL; HQP1351; Prophylactic therapy

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival（DFS）

  The time from the date of transplantation to leukemia relapse

  2 years

Secondary Outcomes (3)

• Overall survival(OS)

  2 years

• Relapse rate

  2 years

• Adverse effects of TKI therapy

  2 years

Study Arms (1)

HQP1351 prophylactic therapy

EXPERIMENTAL

HQP1351 prophylactic therapy after allo-hct on days 30 to 60

Drug: HQP1351( Olverembatinib dimesylate)

Interventions

HQP1351( Olverembatinib dimesylate) DRUG

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

HQP1351 prophylactic therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• xuna: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Guangdong Second Provincial General Hospital: collaborator

Study Sites (1)

Department of Hematology, Nanfang Hospital, Southern Medical University,

Guanzhou, China

Location

MeSH Terms

Interventions

olverembatinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 3, 2022
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)