Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study

Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for Measurable Residual Disease Persisting Acute Myeloid Leukemia: a Prospective, Single-arm, Multicenter Clinical Study

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.

Inclusion Criteria:

• 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);
• Non pregnant and lactating women. For all women of childbearing age, a pregnancy test must be conducted to determine hCG levels in order to exclude pregnancy status;
• For all men of childbearing age, contraceptive measures must be taken during sorafenib treatment until 3 months after discontinuation.

Exclusion Criteria:

• 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;
• Severe organ dysfunction such as heart, liver, kidneys, lungs, etc.