Sign in

NCT04263181Active, not recruiting

AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

Identification of AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

Source: ClinicalTrials.gov · Last updated 2 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
80 (actual)
First submitted
6 Feb 2020
Start date
29 Jan 2020
Primary completion date
31 Jan 2027
Lead sponsor
Washington University School of Medicine
NCT number
NCT04263181

What you commit to

  • Study type: Observational
  • Participants enrolled: 80
  • From 29 Jan 2020 to the primary completion date, 31 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Lab values

  • 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.

Other

  • Pregnant or currently nursing

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Washington University School of Medicine
Coordinator of this site? Confirm its status		St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.