Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML (NCT07511062) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML
United States32 participantsStarted 2026-08-01
Plain-language summary
Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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