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

Study Overview
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Brief Summary
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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.

Official Title
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Treatment With Olverembatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Failed to at Least Two Previously Administered Second-generation Tyrosine Kinase Inhibitors: a Prospective, Single-arm Clinical Trial.

Conditions
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Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase, Tyrosine Kinase Inhibitors

Intervention / Treatment
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* Drug: olverembatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: olverembatinib<br>40mg, taken orally once every other day of a 28-day cycle | Drug: olverembatinib<br>* olverembatinib, 40mg, taken orally once every other day of a 28-day cycle<br>* Other names: HQP1351;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test. | Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with MMR at 3, 6, 9 months. |  | 3, 6, 9 months. | 
| The proportion of patients with MR 4.0 at 3, 6, 9, 12 months. | Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent. | 3, 6, 9, 12 months. | 
| Proportion of patients with MR 4.5 at 3, 6, 9, 12 months. | Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent. | 3, 6, 9, 12 months. | 
| Progression free survival (PFS) | PFS is defined as the interval between the first dose date and the first date at which the criteria for progression are met, or death. | 12 months | 
| Overall survive (OS) | OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive. | 12 months | 
| Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib. | Evaluation of adverse events (AEs), serious AEs (SAEs) | 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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olverembatinib, CML-CP