Clinical trial NCT02581917: Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia
Official title: A Study of the Metabolic Changes in Leukemia Cells Following Treatment in AML Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Acute Myeloid Leukemia (AML)

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.

Eligibility 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).

Primary outcomes:
measure: Glycolytic flux rate
timeFrame: Up to 72 hours after starting chemotherapy
measure: Level of fatty acid synthase by western blot
timeFrame: Up to 72 hours after starting chemotherapy
measure: Number of mononuclear cells per sample determined by cell isolation
timeFrame: Up to 72 hours after starting chemotherapy
measure: Oxygen consumption rate
timeFrame: Up to 72 hours after starting chemotherapy
measure: Number of viable samples
timeFrame: Up to 72 hours after starting chemotherapy
measure: Level of hexokinase by western blot
timeFrame: Up to 72 hours after starting chemotherapy
measure: Level of phosphofructokinase-1 by western blot
timeFrame: Up to 72 hours after starting chemotherapy
measure: Level of phosphoglycerate mutase by western blot
timeFrame: Up to 72 hours after starting chemotherapy
measure: Total level of pyruvate kinase M2 by western blot
timeFrame: Up to 72 hours after starting chemotherapy
measure: Level of pyruvate kinase M2 for phospho-T105 by western blot
timeFrame: Up to 72 hours after starting chemotherapy
measure: Level of phosphofructokinase-2 by western blot
timeFrame: Up to 72 hours after starting chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Timothy Pardee
role: PRINCIPAL_INVESTIGATOR
References: