The purpose of this study is to explore the efficacy and safety of sorafenib combined with venetoclax as pre-emptive therapy strategy for measurable residual disease persisting acute myeloid leukemia.
Voluntary signing of informed consent form;
Liver and kidney function: Blood bilirubin ≤ 35 μ mol/L, AST/ALT < 2 times the upper limit of normal, blood creatinine ≤ 150 μ mol/L;
Normal heart function (EF ≥ 50%, NYHA I/II);
Physical condition score 0-2 (ECOG score);
Acute promyelocytic leukemia;
Hematological non-remisssion or recurrence;
Uncontrolled infection or grade 3-4 graft-versus-host disease (GVHD);
Allergies or contraindications to any of the drugs involved in the protocol;
Single group
Sorafenib (SORA)
DrugSorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
Venetoclax (VEN)
DrugVenetoclax (VEN) was administered at 400mg/day on days 1 to 28.
Molecular response rate after three courses of treatment
After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment
MRD negative rates after three courses of treatment
MRD negative rates after three courses of treatment
Cumulative incidence of relapse (CIR)
Will calculate time from hematological complete rate until relapse.
Event-free survival (EFS)
Will calculate time from assignment until relapse or disease progression.
Overall survival (OS)
Will calculate time from assignment until death from any cause.
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This trial is not recruiting at the moment. You can still explore other options:
