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AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

Recruiting
18 years and older
All
Phase N/A

Overview

In this study, the investigators will explore the feasibility of ex vivo drug screening to predict sensitivity to chemotherapy resistance and to identify novel synergy between chemotherapies.

Eligibility

Inclusion Criteria:

  • Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
  • Peripheral blood blasts > 1%
  • Peripheral white blood cell count > 1,000/l.
  • Age 18 years
  • Anticipated treatment with any of the following regimens (Cohort 0) or:
  • Cohort 1: A standard induction protocol with cytarabine and idarubicin
  • 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
  • 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 3 sample is collected.
  • ECOG performance status 3
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

  • Pregnant or currently nursing
  • Prior chemotherapy with hypomethylating agents
  • Known history of positive HIV serology.
  • Known history of positive Hepatitis C serology.
  • 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, but must discontinue at the time of enrollment. Prior TKI therapy is allowed, but must be discontinued within 3 days of baseline blood collection.
  • Currently receiving any other investigational agents.

Study details
    Preleukemia
    Acute myeloid leukemia
    Acute myeloid leukemia
    MYELODYSPLASTIC SYNDROME

NCT04263181

Washington University School of Medicine

16 February 2024

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