Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients
Northside Hospital, Inc.
Summary
Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDecitabine
20mg/m2/d x5 days (induction \& consolidation)
- DrugVenetoclax
400mg/d x14 days (induction); 400mg/d x7 days (consolidation)
- DrugAxatilimab
Dose escalation, given on Days 1 and 15 of each cycle
Location
- Northside Hospital, Inc.Atlanta, Georgia