chronic myeloid leukemia
Conditions
Interventions
treatment group:Orebatinib
Sponsors
First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Male or female patients =18 years of age 2: Physical strength ECOG PS score =2 points 3: Patients diagnosed with CML-CP 4: The presence of any previous failure or intolerance to first - or second-generation TKI therapy 5: Adequate end-organ function 6: Electrolyte value is within normal range 7: Evidence of typical BCR-ABL1 transcripts [e14a2 and/or e13a2] suitable for standardized RQ-PCR quantification was present at screening 8: The expected survival is greater than 24 weeks 9: Patients are fully aware of the study, voluntarily participate and sign informed consent 10: If compliance is expected to be good, the efficacy and adverse reactions will be followed up according to protocol requirements.
Exclusion criteria
Exclusion criteria: 1: Patients with grade III or higher congestive heart failure (NYHA classification), uncontrolled or unstable angina, or thrombotic disease such as myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months prior to screening 2: Patients with arrhythmia requiring treatment or QTc interval (QTcB)>480ms at the time of screening 3: History of acute or chronic liver disease, acute or chronic kidney disease, acute or chronic chronic pancreatitis 4: A known history of human immunodeficiency virus (HIV) and active hepatitis B or C are present 5: A woman who is pregnant or planning to become pregnant, or a woman who is breastfeeding 6: Combined with other serious medical conditions (including a history of severe neurological or mental illness) 7: Patients with a known or expected allergy or intolerance to the active ingredient or excipient ingredient of the investigational drug 8: The investigators determined that patients were not suitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major molecular response ; | — |
Secondary
| Measure | Time frame |
|---|---|
| BCR-ABL ;Cytogenetic reaction; | — |
Countries
CHINA
Contacts
Public ContactHuang Jian
First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed