Acute myeloid leukemia
Conditions
Interventions
control group:conventional intensive chemotherapy
Experimental group:conventional intensive chemotherapy+HHT
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Core-binding factor (CBF) AML with molecular diagnosis of RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or of CBFB-MYH11 fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) ; 2. Rule out MDS history and secondary AML; 3. Aged 18~60 years; 4. Liver and renal function: serum bilirubin<=35umol/L, AST/ALT lower than 2* upper normal serum level, creatinine<=150umol/L; 5. Normal cardiac function: NYHA I/II; 6. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 7. No prior chemotherapy for leukemia during the diagnostic screening phase (in patients with WBC<50*109/L), except hydroxyurea and/or Cytarabine for up to 5 days (in patients with WBC=50*10^9/L); 8. Non-pregnant and non-nursing; 9. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test to rule out pregnancy; 10. Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking dasatinib and for 3 months after therapy is stopped; 11. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous MDS history, treatment related AML;Acute Mixed-lineage leukemia; AML patients with central nervous system infiltration and extramedullary lesions during the diagnostic screening phase; 2. Previously treated patients; 3. Allergy to any medication in the regimen; 4. Myocardial infarction, pericardial effusion (CTCAE Grade>2); ECG QTc>470ms; 5. Pulmonary disease: pulmonary edema, pleural effusion (CTCAE Grade>2) 6. Patients with a "currently active" second malignancy; 7. Patients with "currently active" tuberculosis. Patients with HIV;active HBV, HCV, or Hepatitis A infection; 8. Patients with other hematological disease (including disturbance of blood coagulation not caused by AML); 9. Patients who can't understand or obey the protocol; 10.Patients participated in other clinical trial; 11. Other circumstance that obstructs the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival;Overall Survival;Complete Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early Death Rate;Toxicity and Satety; | — |
Countries
China
Contacts
Public ContactJunmin Li
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Outcome results
None listed