AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

Running, not enrolling

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT04263181

Run by

Washington University School of Medicine

People needed

80

Starts

2020-01-29

Expected to finish

2027-01-31

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or currently nursing
• Prior chemotherapy with hypomethylating agents
• Known history of positive HIV serology.
• Known 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 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.
• Currently receiving any other investigational agents.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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