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

Starting soon · Phase 1

Conditions studied: Acute Myeloid Leukemia, TP53 Gene Mutation

In brief

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

Key facts

Study ID

NCT07511062

Run by

Northside Hospital, Inc.

People needed

32

Starts

2026-08-01

Expected to finish

2030-08-01

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Northside Hospital, Inc. — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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