AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

Korábbi kezelés

• Prior chemotherapy with hypomethylating agents
• Currently receiving any other investigational agents.

Más betegség

• Known history of positive HIV serology.
• Known positive Hepatitis C serology.

Laborértékek

• Patient must not have received any chemotherapy within 7 days of enrollment, and any acute treatment-related toxicities must have returned to baseline. Patients may have received hydrea as long as they fulfill peripheral blood blast and peripheral WBC inclusion criteria. Prior TKI therapy is allowed, but must be discontinued within 3 days of baseline blood collection.

Egyéb

• Pregnant or currently nursing

• 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.