NCT02581917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 21, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

3.9 years

First QC Date

August 10, 2015

Last Update Submit

October 19, 2022

Conditions

Recurrent Adult Acute Myeloid LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (1)

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 ProcedureOther: Laboratory Biomarker Analysis

Interventions

Cytology Specimen Collection ProcedureOTHER

Undergo collection of PBMC samples

Also known as: Cytologic Sampling
Ancillary-Correlative (metabolic changes)
Laboratory Biomarker AnalysisOTHER

Undergo metabolic analysis

Ancillary-Correlative (metabolic changes)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with Acute Myeloid Leukemia (AML)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Timothy Pardee

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

October 21, 2015

Study Start

April 21, 2017

Primary Completion

April 1, 2021

Study Completion

April 30, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(1)