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Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

A Study of the Metabolic Changes in Leukemia Cells Following Treatment in AML Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02581917
Enrollment
14
Registered
2015-10-21
Start date
2017-04-21
Completion date
2022-04-30
Last updated
2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

Brief summary

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

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.

Interventions

OTHERCytology Specimen Collection Procedure

Undergo collection of PBMC samples

OTHERLaboratory Biomarker Analysis

Undergo metabolic analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Glycolytic flux rateUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of fatty acid synthase by western blotUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Number of mononuclear cells per sample determined by cell isolationUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or analysis of variance (ANOVA) procedures. Other inferential statistical analysis will be conducted as appropriate.
Oxygen consumption rateUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Number of viable samplesUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of hexokinase by western blotUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of phosphofructokinase-1 by western blotUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of phosphoglycerate mutase by western blotUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Total level of pyruvate kinase M2 by western blotUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of pyruvate kinase M2 for phospho-T105 by western blotUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of phosphofructokinase-2 by western blotUp to 72 hours after starting chemotherapyResults will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026