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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
• Intervention / Treatment: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Acute Myeloid Leukemia (AML)

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Cytology Specimen Collection Procedure; Undergo collection of PBMC samples; Other Names: Cytologic Sampling; Other: Laboratory Biomarker Analysis; Undergo metabolic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycolytic flux rate	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.	Up to 72 hours after starting chemotherapy
Level of fatty acid synthase by western blot	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.	Up to 72 hours after starting chemotherapy
Number of mononuclear cells per sample determined by cell isolation	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.	Up to 72 hours after starting chemotherapy
Oxygen consumption rate	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.	Up to 72 hours after starting chemotherapy
Number of viable samples	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.	Up to 72 hours after starting chemotherapy
Level of hexokinase by western blot	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.	Up to 72 hours after starting chemotherapy
Level of phosphofructokinase-1 by western blot	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.	Up to 72 hours after starting chemotherapy
Level of phosphoglycerate mutase by western blot	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.	Up to 72 hours after starting chemotherapy
Total level of pyruvate kinase M2 by western blot	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.	Up to 72 hours after starting chemotherapy
Level of pyruvate kinase M2 for phospho-T105 by western blot	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.	Up to 72 hours after starting chemotherapy
Level of phosphofructokinase-2 by western blot	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.	Up to 72 hours after starting chemotherapy

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Timothy Pardee, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: IRB00034202; P30CA012197 (U.S. NIH Grant/Contract); NCI-2015-01267 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 22A15 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No