A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia

Eligibility Criteria • The following groups of participants will be eligible: * Participants \> 18 years of age with relapsed and/or refractory (defined as \>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or * Participants \>18 years of age with persistent measurable residual disease by flow cytometry or next generation sequencing KMT2A-r B-cell ALL or * Newly diagnosed participants with KMT2A-r B-cell ALL \> 60 years old or unfit for intensive chemotherapy Unfit for intensive chemotherapy defined as: * ECOG \>2 * Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \<50%, or chronic stable angina) * Severe pulmonary disorder (e.g., DLCO \<65% or FEV1 \<65%) * Creatinine clearance \<45 ml/min * Hepatic disorder with total bilirubin 1.5 x upper limit of normal * Performance status \<2 per ECOG scale (for R/R participants) * Adequate liver function as defined by the following criteria: * Total serum bilirubin \<1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 x ULN * Adequate pancreatic function as define by serum lipase and amylase \< 1.5 x ULN * For females of childbearing potential, a negative pregnancy test must be documented (negative serum pregnancy test performed at the time of screening and negative serum or urine pregnancy test prior to the first dose of study drug) * The effects of blinatumomab and revumenib on the developing human fetus …