Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
- 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 Design
Arms and Interventions
| Arm | 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:
Other: Laboratory Biomarker Analysis
Undergo metabolic analysis
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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 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 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.
- 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.
- 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 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.
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Timothy Pardee, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00034202
- NCI-2015-01267
- CCCWFU 22A15
- P30CA012197