Chronic myeloid leukemia
Conditions
Interventions
A:Yinishu (dasatinib)70mg/d
B:Yinishu (dasatinib)100mg/d
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 14-65 years, gender is not limited, race is not limited; 2) New diagnosed patients with chronic phase of chronic myeloid leukemia confirmed by clinical diagnosis (patients who have not received TKI or who have received TKI for more than 1 month; diagnosis and staging criteria for chronic myeloid leukemia according to the ELN guidelines, see attachment) The time from diagnosis to TKI treatment is no more than 6 months, and the expected survival period is more than 12 months; 3) ECOG physical condition 0-2 points; 4) The main organs function is normal, as follows: Serum bilirubin = the lower limit of normal value, or corrected to the normal range before administration; 5) The plasma or urine pregnancy test for women of childbearing age(minimum sensitivity of 25 IU/L or equivalent unit of HCG) must be negative within 72 hours prior to the start of study drug treatment. Also, women of childbearing age must adopt appropriate contraception throughout the study period. Measures to avoid conception in this manner should be taken 1 month before start of the study and at least 3 months after the study, thereby minimizing the risk of conception; 6) Subjects volunteered to participate in and sign the informed consent form, and the process of signing the informed consent form complies with the GCP requirements.
Exclusion criteria
Exclusion criteria: 1) Patients with accelerated or blast period; 2) Pleural effusion, pulmonary hypertension or other serious lung diseases occurred within 3-6 months before enrollment; 3) Stroke, intracranial hemorrhage or gastrointestinal bleeding occurred within 3-6 months prior to enrollment; clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, confirmed or Suspected congenital long QT syndrome or myocardial infarction within 6 months prior to screening, ECG QT interval > 460 ms or any cardiac function grade 3 (moderate) or grade 4 (severe) heart disease; 4) Severe dysfunction of other organs: abnormal renal function, acute hepatitis B, cardiac ejection fraction 3mg/dl, abnormal liver function test results, known to have human immunodeficiency Viral (HIV) infection (optional for HIV testing) or any active infectious disease; central nervous system disorders, psychosis; patients refuse to agree to receive the above treatment and signature; 5) Patients with other refractory malignant diseases; 6) Females of childbearing age or males who are unable to use adequate methods for contraception, including pregnant or lactating females; 7) Allergic persons; or known to have an allergic or adverse drug reaction to previous dasatinib treatment; patients currently taking a strong inducer or strong inhibitor of CYP3A4 or the drugs possibly prolonging the QT interval and cannot temporarily terminate such drugs or use other alternatives; 8) Researchers believe that patients who are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The CCyR rate at 12months;The MMR rate at 12months;median time to achieve CCyR;median time to achieve MMR; | — |
Secondary
| Measure | Time frame |
|---|---|
| The optimal respons rate at 3months;The optimal respons rate at 6 months;The optimal respons rate at 12 months;The MR4.0 rate at 12months;The PFS rate at 12 months;The OS rate at 12 months;Hematological toxicity related to the drug;Non-hematological toxicity related to the drug; | — |
Countries
China
Contacts
Public ContactLi Weiming
Wuhan Union Hospital
Outcome results
None listed