AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration

STATUS

Recruiting
End date

Jan 31, 2025
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	18-100 years
Treatment	Peripheral blood draw, Bone marrow aspirate, Buccal swab
Clinical Study Identifier	NCT04263181
Sponsor	Washington University School of Medicine
Last Modified on	19 February 2024

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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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AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration