Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients

Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients

Inclusion Criteria:

• MDS/AML or AML with a TP53 mutation or deletion, defined as:
• greater than or equal to 10% AND (one of the following):
• presence of a TP53 mutation
• presence of a TP53 deletion by FISH
• positive TP53 staining on IHC of diagnostic bone marrow
• Either untreated or first salvage (primary refractory or first relapse)

Exclusion Criteria:

• KPS <60
• active uncontrolled infection
• history of HIV or active HBV or HBC infection
• currently active second malignancy
• calculated CrCl <40mL/min
• AST and/or ALT and/or direct bilirubin >3x ULN
• cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias
• history of acute or chronic pancreatitis, history of myositis
• known leukemia involvement of CNS
• hematopoietic stem cell transplantation within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade 2+ related to the transplant
• active acute or chronic GVHD requiring immunosuppressive treatment