Identification of AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration IDENTIFICATION OF DRUG SENSITIZATION

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Exclusion Criteria:

* 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.

Additional Trial Information

Enrollment: 165 patients (estimated)

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Trial Locations

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Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting
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