AML
Conditions
Interventions
experimental group:DCAG-lite
Sponsors
Cancer Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
60 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients with 60 years old or more; 2) Elderly AML patients (non-AML-M3) diagnosed according to 2016 World Health Organization (WHO) Diagnostic Criteria for myeloid malignancies; 3) ECOG behavioral status score is 0-2; 4) Bone marrow morphology suggested active myelodysplastic or more than 3; 5) Expected survival time >= 3 months; 6) No serious heart, lung, liver and kidney diseases; 7) No radiotherapy or chemotherapy targeted therapy or hematopoietic stem cell transplantation was performed within 3 weeks before enrollment; 8)Able to understand and willing to sign informed consent to the study.
Exclusion criteria
Exclusion criteria: 1) Previous allergies to drugs included in the protocol or to drugs with a chemical structure similar to that of the drug under test 2) There is a severe active infection 3) Patients with chronic drug and alcohol abuse that affect the evaluation of trial results 4) Has a mental disorder or other medical condition and is unable to obtain informed consent to complete the trial treatment and examination procedures 5) Have clinical significance in patients with a history of QTc duration between (men > 450 ms, women 470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), the above II degrees heart block, the onset of myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and symptomatic drug treatment of patients with coronary heart disease; B-ultrasonography showed the width of liquid dark area in end-diastolic pericardial cavity >= 10mm 6) A patient receiving an organ transplant 7) Patients with active bleeding; 8) Patients with new thrombosis, embolism, cerebral hemorrhage or other diseases or medical history within the last 1 year; 9) Less than 6 weeks after the major organ surgery; 10) Abnormal liver function (1.5 times of the upper limit of the normal value of total bilirubin >, 2.5 times of the upper limit of the normal value of ALT/AST > or 5 times of the upper limit of the normal value of ALT/AST > in patients with liver injury) and renal function (1.5 times of the upper limit of the normal value of serum creatinine >); 11) The researchers judged the participants unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;PFS; | — |
Countries
China
Contacts
Public ContactStephen Yang
Cancer Hospital of Sun Yat-Sen University
Outcome results
None listed