Acute Myeloid Leukemia (AML)
Conditions
Interventions
Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 µg/day, to be discontinued when neutrophils recover and white blood cell count is =20,000/µL
CACAG-VEN:The entire treatment period for the CACAG+Venetoclax regimen in the trial is 1 week, with a treatment cycle of every 4 weeks, and a total of 1 course of treatment.
Chidamide: 30 mg, twice a
Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, used in combination with azoles, with a reduced dosage of 100 mg/day.
contrl group:IA Regimen:
Idarubicin: 8-10 mg/m^2 on days 1 to 3
Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or DA Regimen:
Daunorubicin: 60 mg/m^2 on days 1 to 3
Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
OR
Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg from day 3 to day 28.
Azacitidine: 75 mg/m^2 from day 1 to day 7.
Sponsors
The Fifth Medical Center of the General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures; 2. Age between 60-75 years at the time of screening, with no gender restrictions; 3. Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition; 4. No severe allergic constitution; 5. Liver function: ALT and AST <= 2.5 times the upper limit of normal values, bilirubin <= 2 times the upper limit of normal values; 6. Renal function: creatinine <= upper limit of normal values; 7. No uncontrollable infections or severe mental illnesses; 8. Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to the study medication or have contraindications to it; 2. Pregnant or breastfeeding women; 3. Patients with active infections; 4. Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results; 5. Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures; 6. Patients who have undergone major organ surgery within the last 6 weeks; 7. Abnormal liver function, with total bilirubin > 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT/AST > 5 times the upper limit of normal; abnormal renal function, with serum creatinine > 1.5 times the upper limit of normal; 8. Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Remission with Incomplete Blood Count Recovery;Partial Response;Overall Survival;Event-Free Survival;Overall Response Rate;Minimal Residual Disease; | — |
Countries
China
Contacts
Public ContactLiping Dou
The Fifth Medical Center of General Hospital of the People's Liberation Army
Outcome results
None listed