A Phase II Study of Decitabine in Combination With Midostaurin (PKC412) for Elderly Patients With Newly Diagnosed FLT3-ITD/TKD Positive Acute Myeloid Leukemia
This phase II trial studies how well giving decitabine together with midostaurin works in treating older patients with newly diagnosed acute myeloid leukemia. Decitabine and midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- drug : decitabine
- drug : midostaurin
- other : laboratory biomarker analysis
Phase: Phase 2
Ages Eligible For Study:
- Newly diagnosed AML (according to the World Health Organization [WHO] 2008 classification) except t(15;17), including: - De novo AML - Secondary AML - Secondary AML arising from previously diagnosed myelodysplastic syndromes (MDS) treated with deoxyribonucleic acid (DNA) methyltransferase inhibitor (DNMTi) (i.e., decitabine or azacitidine) - Confirmed FLT3-ITD or FLT3-TKD mutation, measured on bone marrow aspirate as part of screening prior to study enrollment; sample will be submitted to Stanford clinical lab and sent out for commercially available test at Laboratory for Personalized Molecular Medicine - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) - Serum bilirubin =< 2.5 x ULN - Serum creatinine =< 1.5 mg/dL and/or creatinine clearance >= 50 mL/min - Ejection fraction >= 50% by echocardiogram - Unwillingness or inability to receive conventional chemotherapy - Ability to understand and the willingness to sign a written informed consent document - Ability to adhere to the study visit schedule and other protocol requirements - Life expectancy of greater than two months