AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

  • STATUS
    Recruiting
  • participants needed
    165
  • sponsor
    Washington University School of Medicine
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Updated on 19 February 2024
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myeloid leukemia
cytarabine
idarubicin
azacitidine
myelodysplastic syndromes
gemtuzumab ozogamicin
decitabine
leukemia
bone marrow procedure
venetoclax
blood cell count
aml/mds
midostaurin
gemtuzumab
acute myeloid leukemia
myelodysplastic syndrome
aml

Summary

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.

Details
Condition Preleukemia, Acute myeloid leukemia, Acute myeloid leukemia, MYELODYSPLASTIC SYNDROME
Age 18years - 100years
Treatment Peripheral blood draw, Bone marrow aspirate, Buccal swab
Clinical Study IdentifierNCT04263181
SponsorWashington University School of Medicine
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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myeloid leukemia
cytarabine
idarubicin
azacitidine
myelodysplastic syndromes
gemtuzumab ozogamicin
decitabine
leukemia
bone marrow procedure
venetoclax
blood cell count
aml/mds
midostaurin
gemtuzumab
acute myeloid leukemia
myelodysplastic syndrome
aml

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