Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Second People's Hospital

Criteria

Inclusion Criteria:

• Age ≥ 18 years and ≤75 years.

• Diagnosis of CML-CP.

• ECOG performance of 0-2.

• Adequate end organ function defined as the following: total bilirubin <1.5xULN, SGPT <2.5x ULN, creatinine <1.5x ULN.

• Resistance and/or intolerance of at least two second-generation TKIs.

• Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

• Known to be allergic to study drug ingredients or their analogues.

• History of undergone major surgery within 4 weeks.

• Patients unwilling or unable to comply with the protocol.

• Pregnant or breast-feeding patients.

• patients with other malignant tumor.