Leukemia
Conditions
Interventions
Group A:TKI + chemotherapy
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, aged >= 18 years; 2. Diagnosed as CBF-AML according to WHO standards, with KIT mutation; 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 1.5 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: 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, 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 |
|---|---|
| measurable residual disease, MRD; | — |
Secondary
| Measure | Time frame |
|---|---|
| hematological relapse; | — |
Countries
China
Contacts
Public ContactQian Jiang
Peking University People's Hospital
Outcome results
None listed