Clinical Research Directory

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