Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

Recurrent Adult Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581917
• Other study ID #: IRB00034202
• Secondary ID: NCI-2015-01267CC
• Status: Completed
• Start date: April 21, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 30, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrent Adult Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo collection of PBMC samples
• Laboratory Biomarker Analysis
Undergo metabolic analysis

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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