Chronic myeloid leukemia
Conditions
Interventions
experimental group:Olverembatinib
Control group:Another second-generation tyrosine kinase inhibitor
Sponsors
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1)Age = 18 years old; 2)At the time of enrollment, the patient is in the chronic phase of CML; 3)Since the diagnosis of CML, the patient has never entered an accelerated or blast phase; 4)ECOG = 2; 5)TKI treatment was initiated within 3 months after the diagnosis of CML, and the patient has used one of the second-generation TKIs for more than 12 months (including dasatinib, nilotinib, or imatinib) without achieving a major molecular response and/or is intolerant; 6)The patient is a voluntary participant, who, after fully understanding the nature of the trial, the purpose of the trial, the expected benefits and potential risks, and the results of previous related studies, voluntarily agrees to participate in this trial and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1)Detected presence of the T315I mutation at any time point; 2)Diagnosed with CML-AP (accelerated phase) or CML-BC (blast crisis) at any time; 3)Treated with ponatinib or asciminib (ABL001); 4)Patients with severe hepatic or renal dysfunction (ALT > 3 times the upper limit of normal, AST > 3 times the upper limit of normal); 5)eGFR 460ms); 7)History of significant hemorrhagic disorders unrelated to CML; 8)Patients with concurrent other malignancies; 9)Patients with active, uncontrollable mental disorders, including: psychosis, severe depression, and bipolar affective disorder; 10)Other conditions deemed unsuitable for clinical observation by the investigator; 11)Participation in any other clinical trial within 4 weeks prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving major molecular response (MMR) at 12 months after treatment with olverembatinib or another second-generation TKI.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rates of complete cytogenetic response (CCyR) and molecular response level 4 (MR4) at 12 months post-treatment switch, as well as the cumulative incidence of MR4.;The proportion of patients achieving major molecular response (MMR) and molecular response level 4 (MR4) at 3, 6, and 12 months post-treatment switch.;Assess the progression-free survival and overall survival.; | — |
Countries
China
Contacts
Public ContactZhu Yu
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Outcome results
None listed