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NCT Number: NCT02581917

Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

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.

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Key information

Conditions

Recurrent Adult Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Untreated Adult Acute Myeloid Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo collection of PBMC samples

Other names: Cytologic Sampling

laboratory biomarker analysis

Other

Undergo metabolic analysis

Primary outcomes

  1. Glycolytic flux rate

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  2. Level of fatty acid synthase by western blot

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  3. Number of mononuclear cells per sample determined by cell isolation

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  4. Oxygen consumption rate

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  5. Number of viable samples

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  6. Level of hexokinase by western blot

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  7. Level of phosphofructokinase-1 by western blot

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  8. Level of phosphoglycerate mutase by western blot

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  9. Total level of pyruvate kinase M2 by western blot

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  10. Level of pyruvate kinase M2 for phospho-T105 by western blot

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

  11. Level of phosphofructokinase-2 by western blot

    Time frame: Up to 72 hours after starting chemotherapy

    Results 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 21, 2015
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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