Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

NCT ID: NCT02581917

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-21

Study Completion Date

2022-04-30

Brief Summary

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This research trial studies metabolic changes in blood samples from patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help doctors learn more about cancer and the development of drug resistance.

Detailed Description

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PRIMARY OBJECTIVES:

I. To determine the metabolic adaptations that occur following exposure to standard chemotherapeutic agents using peripheral blood mononuclear cells from acute myeloid leukemia (AML) patients.

OUTLINE:

Patients undergo collection of peripheral blood mononuclear cell (PBMC) samples for analysis via cell isolation, glycolytic flux and oxygen consumption assays, viability assays, and western blot at baseline, 24, 48, and 72 hours after starting chemotherapy.

Conditions

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Recurrent Adult Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ancillary-Correlative (metabolic changes)

Patients undergo collection of PBMC samples for analysis via cell isolation, glycolytic flux and oxygen consumption assays, viability assays, and western blot at baseline, 24, 48, and 72 hours after starting chemotherapy.

Cytology Specimen Collection Procedure

Intervention Type OTHER

Undergo collection of PBMC samples

Laboratory Biomarker Analysis

Intervention Type OTHER

Undergo metabolic analysis

Interventions

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Cytology Specimen Collection Procedure

Undergo collection of PBMC samples

Intervention Type OTHER

Laboratory Biomarker Analysis

Undergo metabolic analysis

Intervention Type OTHER

Other Intervention Names

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Cytologic Sampling

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to initiate chemotherapy for either an initial diagnosis of AML or relapsed AML
* Starting the initial induction phase of therapy
* Exposure to hydroxyurea is acceptable but must be noted at the time of sample collection
* Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent

Exclusion Criteria

* Received at least one dose of chemotherapy during the current cycle (excluding hydroxyurea).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Pardee

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-01267

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 22A15

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00034202

Identifier Type: -

Identifier Source: org_study_id

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