Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

Completed

• Conditions: Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
• Interventions: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02581917
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-21
• Study Start: 2017-04-21
• Primary Completion: 2021-04-01
• Study Completion: 2022-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

• Received at least one dose of chemotherapy during the current cycle (excluding hydroxyurea).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (metabolic changes)	Laboratory Biomarker Analysis	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.
Ancillary-Correlative (metabolic changes)	Cytology Specimen Collection Procedure	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.

Primary Outcome Measures

Name	Time	Method
Number of mononuclear cells per sample determined by cell isolation	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.
Level of pyruvate kinase M2 for phospho-T105 by western blot	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.
Level of phosphofructokinase-2 by western blot	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.
Level of fatty acid synthase by western blot	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.
Oxygen consumption rate	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.
Glycolytic flux rate	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.
Number of viable samples	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.
Level of phosphofructokinase-1 by western blot	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.
Total level of pyruvate kinase M2 by western blot	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.
Level of hexokinase by western blot	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.
Level of phosphoglycerate mutase by western blot	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.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States