AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

Inclusion Criteria

• •Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
• •Peripheral blood blasts \> 1%
• •Peripheral white blood cell count \> 1,000/µl.
• •Age ≥ 18 years
• •Anticipated treatment with any of the following regimens (Cohort 0) or:
• •* Cohort 1: A standard induction protocol with infusional cytarabine
• •* Cohort 2: Decitabine (either 5-day or 10-day regimens)
• •* Cohort 3: Azacitidine (either intravenous or subcutaneous administration)
• •* Cohort 4: Decitabine (either 5-day or 10-day) + venetoclax
• •* Cohort 5: Azacitidine (either intravenous or subcutaneous administration on 7 day or 5+2+2 schedule) + venetoclax
• •Patients may receive these therapies as part of other on-going clinical trials or as standard of care treatment.
• •Patients in Cohort 1 may receive SOC midostaurin or gemtuzumab ozogamicin, provided these start after the Day 2 sample is collected. Patients in Cohort 1 may receive a standard combination of cytarabine/idarubicin, cytarabine/daunorubicin, or Vyxeos, a liposomal formulation of cytarabine and daunorubicin.
• •ECOG performance status ≤ 3
• •Ability to understand and willingness to sign an IRB approved written informed consent document.
• •Currently receiving any other investigational agents.