Recurrent Adult Acute Myeloid LeukemiaNCT02581917
Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia
An observational study of Recurrent Adult Acute Myeloid Leukemia and Untreated Adult Acute Myeloid Leukemia, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- What is being tested?
- Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2017to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Acute Myeloid Leukemia (AML)
Who may be able to join
- 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
Who cannot join
- Received at least one dose of chemotherapy during the current cycle (excluding hydroxyurea).
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Study of the Metabolic Changes in Leukemia Cells Following Treatment in AML Patients
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.
Read the 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.
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo collection of PBMC samples
Laboratory Biomarker AnalysisOther
Undergo metabolic analysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 72 hours after starting chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start21 Apr 2017
- Primary completion1 Apr 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Timothy Pardee, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581917
- Sponsor's protocol ID
- IRB00034202
- Other IDs
- NCI-2015-01267, CCCWFU 22A15, P30CA012197
- Status last verified
- Oct 2022
- First submitted
- 10 Aug 2015
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Metabolic Changes in Leukemia Cells Following Treatment in AML Patients
- ClinicalTrials.gov ID
- NCT02581917
- Acronym / sponsor ID
- IRB00034202
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (metabolic changes) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Acute Myeloid Leukemia (AML)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Received at least one dose of chemotherapy during the current cycle (excluding hydroxyurea).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo collection of PBMC samples | Other | Ancillary-Correlative (metabolic changes) |
| Laboratory Biomarker AnalysisUndergo metabolic analysis | Other | Ancillary-Correlative (metabolic changes) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Pardee principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Adult Acute Myeloid Leukemia and Untreated Adult Acute Myeloid Leukemia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycolytic flux rate (time frame: Up to 72 hours after starting chemotherapy). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.