Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Inclusion criteria

All of the following:

• Patient must have non-M3 AML or MDS
• An adverse risk karyotype defined by:

• Complex karyotype by cytogenetics, or
• Deletion of all or part of chromosome 5, 7, 12, or 17 defined by FISH or cytogenetics, or
• Somatic TP53 mutation

All of the following:

• Patient must have an ECOG performance status ≤ 2.
• Patient must have >10% disease burden measured by cytomorphology, flow cytometry, or cytogenetics.
• Patient must have peripheral white blood cell count < 50,000/mcl.
• Patient must have adequate organ function, defined as:

• Total bilirubin < 1.5 x ULN
• AST/ALT < 2.5 x ULN
• Serum creatinine < 2.0 x ULN
• Patient must have undergone ≤ 2 cycles of prior hypomethylating agent (decitabine or azacitidine).
• Patient must be enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases").
• Patient must be > 18 years of age.
• Patient must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion criteria

• Patient must not be pregnant or nursing
• Patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH.
• Patient must not have known central nervous system (CNS) leukemia
• Patient must not have a history of positive human immunodeficiency virus (HIV) serology
• Patient must not have a history of positive hepatitis C serology
• Patient must not have undergone prior allogeneic stem cell transplant
• Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, ongoing or active graft-versus-host disease (GVHD), congestive heart failure of New York Heart Association (NYHA) class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Patient must not have had radiation therapy within 14 days of enrollment
• Patient must not have received any chemotherapy within 21 days of enrollment and any acute treatment-related toxicities must have returned to baseline. Patients may be receiving hydrea at time of enrollment.