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

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Status and phase: Withdrawn; Phase 2

Conditions: Prophylactic HQP1351 Therapy; Third Generation TKI

Treatments: Drug: HQP1351( Olverembatinib dimesylate)

Study type: Interventional

Funder types: Other

Identifiers

NCT05604755

PH20221030

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

HQP1351 prophylactic therapy

Experimental group

Description:

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

Treatment:

Drug: HQP1351( Olverembatinib dimesylate)