Acute Myeloid Leukemia
Conditions
Interventions
Trial group:Cytarabine + Venetoclax + Liposomal Mitoxantrone, with specific chemotherapy agents as follows:
Cytarabine: 20 mg/m^2/dose, every 12 hours, subcutaneous injection, days 1–10.
Venetocla
Control group:Cytarabine + Venetoclax + Idarubicin, with specific chemotherapy agents as follows:
Cytarabine: 20 mg/m^2/dose, every 12 hours, subcutaneous injection, days 1–10.
Venetoclax: 200–250
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1.Age=16 years) >=50;
Exclusion criteria
Exclusion criteria: 1.AML secondary to trisomy 21 (Down syndrome) or other genetic disorders; 2.Acute promyelocytic leukemia (APL) with PML/RARa fusion gene positivity; 3.AML transformed from myelodysplastic syndrome (MDS) or secondary AML (therapy-related AML). 4.Death within 3 days of initiating induction therapy or treatment discontinuation due to patient/family refusal; 5.Presence of central nervous system (CNS) sarcoma with spinal cord compression requiring emergency intervention, making the proposed treatment protocol unfeasible; 6.Prior treatment with other chemotherapy regimens for >7 days (excluding low-dose cytoreductive therapy for hyperleukocytosis);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of sepsis during neutropenia;Cardiac damage at various levels;Treatment-related mortality;Minimal residual disease remission rate;Event-free survival and overall survival at a median follow-up of 3 years;Bone marrow suppression, liver and kidney function impairment, and other indicators; | — |
Countries
China
Contacts
Public ContactHuang Libin
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed