Acute myeloid leukemia (AML)
Conditions
Interventions
Experimental group:G-CSF combined with azatidicine and venetoclax
control group:azatidicine and venetoclax
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed, untreated AML who met the WHO2016 hematopoietic and lymphoid tumor classification criteria were not eligible for treatment with standard cytarabine combined with anthracycline due to age or comorbidities (patients treated with hydroxyurea or cytarabine in the early stage were eligible). 2. Aged >= 75 years, or aged 18-74 years with one of the following diseases: ECOG score 2-3; History of congestive heart failure or EF =30ml/min, 1.5 times the upper limit of normal, =75 years, score 0-2. Aged 18-74 years, score 0-3. 6. Creatinine clearance >=30ml/min. 7. Adequate liver function is required: AST<= 3 times the upper limit of normal, ALT<= 3 times the upper limit of normal, bilirubin <= 1.5 times the upper limit of normal (unless leukemic liver involvement is considered). Patients < 75 years of age have bilirubin <= 3 times the upper limit of normal. 8. Sign and fill in the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Previous history of myeloproliferative tumor [MPN]. 2. Have received the following treatments: demethylated drugs for MDS, Venecola, and/or chemotherapy; Experimental treatment for MDS or AML; Participating in other studies. 3. AML involves the central nervous system. 4. HIV, HBV, HCV positive (except those with undetectable viral load within 3 months of screening). 5. Consumed pomelo, pomelo products, Seville oranges, or star fruit within 3 days before starting the study treatment. 6. Have a severe chronic respiratory disease requiring continuous oxygen intake, or a history of severe renal, neurological, psychiatric, endocrine, metabolic, immune, liver, cardiovascular disease, or a known allergy to any investigational drug, including azactidine excipients. 7. Malabsorption syndrome or other conditions that interfere with enteral delivery routes. 8. Combined with tuberculosis or severe infection. 9. A history of other malignancies within the 2 years prior to study entry, other than appropriately treated carcinoma in situ of cervical or breast cancer in situ; Basal cell carcinoma of skin or localized squamous cell carcinoma of skin; The previously limited malignancy was cured by surgical excision (or other treatment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival ;Event-free survival (EFS);Minimal residual disease negative conversion rate; | — |
Countries
China
Contacts
Public ContactPengcheng He
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed