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Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02581917
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Recurrent Adult Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis

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.


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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Metabolic Changes in Leukemia Cells Following Treatment in AML Patients
Actual Study Start Date : September 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


Group/Cohort 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 Name: Cytologic Sampling

Other: Laboratory Biomarker Analysis
Undergo metabolic analysis




Primary Outcome Measures :
  1. Glycolytic flux rate [ Time Frame: 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.

  2. Level of fatty acid synthase by western blot [ Time Frame: 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.

  3. Number of mononuclear cells per sample determined by cell isolation [ Time Frame: 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.

  4. Oxygen consumption rate [ Time Frame: 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.

  5. Number of viable samples [ Time Frame: 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.

  6. Level of hexokinase by western blot [ Time Frame: 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.

  7. Level of phosphofructokinase-1 by western blot [ Time Frame: 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.

  8. Level of phosphoglycerate mutase by western blot [ Time Frame: 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.

  9. Total level of pyruvate kinase M2 by western blot [ Time Frame: 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.

  10. Level of pyruvate kinase M2 for phospho-T105 by western blot [ Time Frame: 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.

  11. Level of phosphofructokinase-2 by western blot [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with Acute Myeloid Leukemia (AML)
Criteria

Inclusion Criteria:

  • Patients scheduled to initiate chemotherapy for either an initial diagnosis of AML or relapsed AML
  • Total white blood cell count > 1000/mcl AND
  • >= 50% leukemic cells in the peripheral blood, as determined by automated differential
  • Only patients starting the initial induction phase of therapy are eligible
  • Patients who have already received 1 or more doses of chemotherapy for their present diagnosis will be excluded
  • Prior exposure to hydroxyurea is acceptable but must be noted at the time of sample collection
  • Patients must have the ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document in order to participate in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581917


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Timothy S. Pardee    336-716-5847    tspardee@wakehealth.edu   
Principal Investigator: Timothy S. Pardee         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Timothy Pardee Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02581917     History of Changes
Other Study ID Numbers: IRB00034202
NCI-2015-01267 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 22A15 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms