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

NCT ID: NCT05604755

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HQP1351 prophylactic therapy

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

Group Type: EXPERIMENTAL

HQP1351( Olverembatinib dimesylate)

Intervention Type: DRUG

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

Interventions

HQP1351( Olverembatinib dimesylate)

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Guangdong Second Provincial General Hospital

OTHER

Sponsor Role: collaborator

xuna

OTHER

Sponsor Role: lead

Responsible Party

xuna

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Hematology, Nanfang Hospital, Southern Medical University,

Guanzhou, , China

Countries

China

Other Identifiers

PH20221030

Identifier Type: -

Identifier Source: org_study_id