Chronic myeloid leukemia
Conditions
Interventions
Olverembatinib dose adjustment group:None
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Diagnosed with chronic myeloid leukemia in the chronic phase, currently receiving olverembatinib 30 mg or 40 mg every other day (QOD). The patient must have achieved and maintained at least two consecutive confirmations of complete cytogenetic response (CCyR) or BCR::ABL1 (IS) <= 1% prior to enrollment and has decided to switch to olverembatinib 20 mg QOD. 3. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 to 2. 4. Signed informed consent must be obtained prior to any study-specific procedures. If the patient is unable to sign due to their medical condition, informed consent may be provided by the legal guardian or an immediate family member. 5. Subjects must be willing and able to comply with all study procedures and the follow-up schedule.
Exclusion criteria
Exclusion criteria: 1. Female patients with a positive serum ß-HCG test, or who are pregnant, breastfeeding, or planning to become pregnant during the study period; 2. Uncontrolled infection at the time of enrollment; or severe complications requiring mechanical ventilatory support or presenting with hemodynamic instability; 3. Inability or unwillingness to provide signed informed consent; 4. Any condition or disease that, in the judgment of the investigator, may compromise subject safety or interfere with the evaluation of the efficacy or safety of the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month CCyR or BCR::ABL1 <=1% rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative MMR rate;Cumulative MR4 rate;Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactQian Jiang
Peking University People's Hospital
Outcome results
None listed