Azacitidine and Ascorbic Acid in Treating Patients with TET2-Mutated Newly Diagnosed, Recurrent, or Refractory Blood Cancer

Inclusion Criteria

• Patients must have a confirmed heterozygous TET2 mutations identified by next generation targeted deep sequencing
• Patients must have MDS, or MDS/MPN overlap defined by 2016 World Health Organization (WHO) criteria; both newly diagnosed or previously treated MDS or MDS/MPN patients are eligible as long as the patient has never received prior treatment with azacitidine or decitabine
• Patients with leukemic/blast phase transformation MPN
• Patient with AML according to 2016 WHO criteria (excluding acute promyelocytic leukemia [APL] [AML-M3])
• Newly diagnosed patients who are ineligible or declined to receive intensive chemotherapy after discussion of risks and benefits of that approach or patients with primary refractory/relapsed AML
• Patients with active central nervous system (CNS) leukemia eligible at the discretion of treating physician
• Relapse/refractory is defined as at least 1 course of treatment for AML excluding any patients treated with azacitidine or decitabine
• Patients should be off any prior treatment or line of therapy for 2 weeks prior to start study with the exception of hydrea (hydroxyurea)
• Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors) or hematopoietic growth factors is allowed
• Eastern Cooperative Oncology Group (ECOG) performance status =< 3
• Patients must have normal organ and marrow function as defined at the discretion of the treating physician and principal investigator (PI)
• Women of childbearing potential must have a negative serum or urine pregnancy test within 10-14 days prior to enrollment
• Patients must have the ability to understand and the willingness to sign a written informed consent document
• Patient must be willing to comply with all aspects of the protocol including completing the drug diary
• Patient must discontinue any and all use of multivitamin and/or vitamin c medication 24 hours before first dose of ascorbic acid

Exclusion Criteria

• Any prior treatment with azacitidine or decitabine
• Patients diagnosed with APL, AML-M3
• Patients receiving other active treatment for their myeloid malignancy including investigational agents with the exception of hydrea for white blood cell (WBC) control
• Nursing or pregnant women
• History of allergic reactions to either azacitidine or ascorbic acid
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with higher risk of bleeding (deemed by the treating physician) or on anticoagulation
• Patients who are unwilling or unable to comply with all study requirements