chronic myeloid leukemia
Conditions
Interventions
flumatinib 600mg qd and 400 mg qd:Single dose
flumatinib 600mg qd and 400 mg qd :multiple consecutive doses
Sponsors
National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Previously or newly diagnosed as chronic phase chronic myeloid leukemia, Male or female patients 18-65 years of age, ECOG 0-1, not expected to progress to accelerated or blast phase within 3 months; 2) No previous use of TKI drugs, including imatinib, nilotinib, dasatinib, flumatinib, etc; 3) No other anti-CML therapy has been used within 2 weeks (except for hydroxyurea therapy, the investigator judged that the patient had no myelosuppression before enrollment); 4) Blood biochemical examination meets the following criteria: Total bilirubin = the lower limit of normal; 5) Patients who must sign informed consent before screening.
Exclusion criteria
Exclusion criteria: 1) Accelerate/ Blast Phase; 2) Previously documented CML-CP with T315I mutation; 3) Patients with central nervous system leukemia or peripheral neuropathy >= grade 2(NCI-CTC); 4) History of malignancy (except for primary chronic myelogenous leukemia); 5) Currently receiving medications containing any unknown ingredients; 6) Need to take CYP3A4 inducers or inhibitors or drugs that may prolong the QT interval; 7) NYHA grade 3 or 4 heart disease or impaired heart function involving any of the following: Uncontrollable angina pectoris; myocardial infarction occurred within 12 months; echocardiogram showed LVEF 450 ms (Male) or QTcF > 470 ms (female); clinically significant ventricular or atrial tachyarrhythmia; 8) Suffering from impaired gastrointestinal function or gastrointestinal diseases that may significantly affect the absorption of the test drug, such as: ulcers, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, after small bowel resection, etc.; 9) History of congenital or acquired bleeding disorders unrelated to CML; 10) Suffering from active, uncontrollable mental illness, such as psychosis, severe depression, bipolar disorder (also called "manic depression"); 11) Patients with chronic kidney disease, patients with hypertension that is not well controlled with antihypertensive medication (resting period SBP >= 150 mmHg and/or DBP >= 100 mmHg), or patients with active and uncontrollable infection (persistent fever and worsening clinical symptoms); 12) Suffering from poorly controlled diabetes, thyroid dysfunction (hyperthyroidism or hypothyroidism); 13) History of immunodeficiency, including HIV positivity, acquired or congenital immunodeficiency diseases, or organ transplantation; 14) Patients with hepatitis B surface antigen positive, core antibody-positive patients with virus replication, or patients with hepatitis C antibody-positive or other acute and chronic liver diseases; 15) People with allergies; or patients who are known to be allergic to or contraindicated to test drugs (API and/or excipients) 16) The pregnant female subjects with fertility had positive pregnancy test within 7 days before the first medication; Female subjects refused to take appropriate and effective contraceptive measures during the study period;Male subjects with no desire for contraception; 17) Entry into another therapeutic clinical trial within 30 days; 18) Other conditions considered inappropriate by the investigator, such as an unwillingness or inability to follow the treatment regimen, including failure to visit on time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration-time curve; | — |
Countries
China
Contacts
Public ContactJianxiang Wang
Outcome results
None listed