acute myeloid leukemia
Conditions
Interventions
treatment group:venetoclax, decitabine/azacitidine, aclarubicin
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Patients with acute myeloid leukemia (AML) diagnosed by bone marrow morphology and immunophenotyping (meeting the WHO 2016 diagnostic criteria). 2. Have experienced relapse or refractory disease to prior chemotherapy. Relapse is defined as the reappearance of leukemia cells in peripheral blood or =5% blasts in bone marrow after achieving CRc (excluding reasons like bone marrow regeneration after consolidation therapy) or extramedullary leukemia cell infiltration. Refractory refers to not achieving CRc after 1 cycle of standard treatment, <50% reduction in bone marrow blasts, or not achieving CRc after 2 cycles of standard treatment. 3. Age between 18 and 69 years old. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) =3x the upper limit of normal (ULN), serum bilirubin =1.5x ULN; serum creatinine =2.0x ULN; serum troponin <2.0x ULN. 6. Left ventricular ejection fraction (LVEF) =50% as measured by echocardiography. 7. Informed consent signed by the patient or their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia; 2. Previously received chemotherapy regimens based on venetoclax (patients with venetoclax treatment duration =14 days, those with <14 days of treatment may be included); 3. Known allergy to any drug involved in the regimen; 4. Pregnant or lactating women and reproductive-age patients unwilling to use contraception measures; 5. Inadequate for clinical trial participation due to existing diseases or medical conditions related to kidney, nervous system, lung, mental health, endocrine system, metabolism, immune system, liver, or other aspects; 6. Presence of structural heart disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or documented myocardial infarction within 6 months prior to screening resulting in clinical symptoms or impaired cardiac function (according to New York Heart Association Functional Classification NYHA =3); 7. Uncontrolled active infection; 8. Active acute/chronic graft-versus-host disease (GVHD) requiring treatment with at least 1 mg/kg/day of prednisone (or equivalent steroid) or non-steroidal therapy; 9. Concurrent malignancies; except for the following: 1) Those who have received curative-intent treatment and have not experienced any known active malignant tumors for =5 years before enrollment; 2) Those who have received adequate treatment and show no evidence of disease for non-melanoma skin cancer or malignant melanocytic nevi (even if less than 3 years before enrollment); 3) Those who have received adequate treatment and show no evidence of disease for in situ carcinoma (even if less than 3 years before enrollment); 10. Unable to understand or comply with the study protocol; 11. Patients under 18 or over 69 years old; 12. Underwent major surgery within 4 weeks before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PR rate;ORR;Recovery time of hematopoietic cells;MRD;OS;EFS;DFS;CIR; | — |
Countries
China
Contacts
Public ContactQian Sun
Jiangsu Province Hospital
Outcome results
None listed