Leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Only patients who meet each of the following inclusion criteria can participate in this study: 1. Male or female, age >= 18 years old 2. Diagnosed as CBF-AML according to WHO standards, with KIT mutation, whose effect was poorly controlled, that is complete remission was not received after one standard induction treatment, molecular continuous positive or relapse. 3. Able to understand and voluntarily sign a written informed consent form, which must be signed before performing any test-specified procedures. 4. ECOG score 5 x ULN, 24-hour creatinine clearance >= 50 mL/min (using Cockcroft-Gault formula, see Annex 3); (2) Serum albumin >= 3.0 g/dL; (3) Serum total bilirubin 50%, pulmonary artery systolic pressure <= 50mmHg 6. Subjects must be willing and able to complete the research procedures and follow-up inspections.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not suitable for participating in this study: 1. Malabsorption syndrome or other diseases that affect the absorption of oral drugs. 2. Another type of malignant tumor (patients who have been cured for = 5 years, or completely resected non-melanoma skin cancer or successfully treated carcinoma in situ, or controlled prostate cancer, the researcher judges that it will not affect the cost The efficacy and safety evaluation of the study can be included in this study). 3. Subjects who are known to be allergic to study drug ingredients or their analogs. 4. Blood ß-HCG-positive female patients, pregnant or lactating female patients, or subjects expecting to become pregnant during the study plan. 5. According to the judgment of the investigator or sponsor, any symptoms or diseases of the subject may affect the safety of the subject or interfere with the effectiveness and safety evaluation of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hematological efficacy;minimal residual disease(MRD); | — |
Countries
China