Chronic Lymphocytic LeukemiaNCT04785989
In Vivo Metabolic Profiling of CLL (Chronic Lymphocytic Leukemia)
An observational study of Chronic Lymphocytic Leukemia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Metabolic reprogramming has been identified as a hallmark of cancer. Almost a century after Otto Warburg initially discovered increased glycolytic activity in tumor tissue ("Warburg effect"), therapeutic targeting of cancer metabolism has become a field of intense research effort in cancer biology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- [U-13C]glucose and [13C5]glutamine
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: To meet the study aims sixteen (16) adult participants will be enrolled: four (4) healthy volunteers defined as people without a history of cancer, 8 patients with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0, and 4 patients with high disease burden CLL defined as having extensive infiltration of the bone marrow.
Who may be able to join
- Group A
- Adult (18 years of age or older)
- No previous history of cancer
- Routine history of normal blood counts and vital signs
- Documented Informed Consent
- Group B
Show all 16Show fewer
- Adult (18 years of age or older)
- Diagnosis of CLL with low disease burden defined as Rai stage 0 ((Lymphocytosis; no enlargement of the lymph nodes, spleen, or liver; red blood cell and platelet counts are near normal.)
- Treatment naïve
- Documented Informed Consent
- Group C
- Adult (18 years of age or older)
- Diagnosis of CLL with high systemic disease burden defined as infiltration of bone marrow causing cytopenia
- Treatment naïve
- Able/willing to have bone marrow aspiration
- Documented Informed Consent
Who cannot join
- For all participants
- Prisoners
- Psychiatric inpatients or people who are institutionalized
- Minor (Less than 18 years of age)
- History of diabetes
- Cannot be on antihyperglycemic therapy
Show all 11Show fewer
- Carbohydrate restricting diets: Atkins, Vegan, Ketogenic, etc.
- Females of child bearing potential
- Persons without decision-making capacity
- Person who cannot read/write English
- Not meeting inclusion criteria defined above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: Metabolic Profiling of Leukemic Cells Through Isotope Tracing in Patients With CLL
Metabolic reprogramming has been identified as a hallmark of cancer. Almost a century after Otto Warburg initially discovered increased glycolytic activity in tumor tissue ("Warburg effect"), therapeutic targeting of cancer metabolism has become a field of intense research effort in cancer biology.
A growing appreciation of metabolic heterogeneity and complexity is currently reshaping investigators "simplistic" understanding of metabolic reprogramming in cancer. Discovering metabolic vulnerabilities as new treatment targets for cancer requires systematic dissection of metabolic dependencies, fuel preferences, and underlying mechanisms in the specific physiological context. However, today's data on cancer cell metabolic signatures and heterogeneity in their physiological habitat of the human organism is sparse to non-existent representing a critical knowledge gap in designing effective metabolic therapies. Here, the investigators propose a "top-down" approach studying cancer cell metabolism in patients followed by mechanistic in-depth studies in cell culture and animal models to define metabolic vulnerabilities.
Investigators will develop a metabolic tracing method to quantitatively characterize metabolic signatures and fuel preferences of leukemic lymphocytes in patients with chronic lymphocytic leukemia (CLL). Isotopic metabolic tracers are nutrients that are chemically identical to the native nutrient. Incorporated stable, non-radioactive isotopes allow investigators to follow their metabolic fate by monitoring conversion of tracer nutrients into downstream metabolites using cutting-edge metabolomics analysis. Using this method, investigators propose to test the hypothesis that leukemic lymphocytes show tissue-specific metabolic preferences that differ from non-leukemic lymphocytes and that ex vivo in-plasma labeling represents a useful model for assaying metabolic activity in leukemic cells in a patient-specific manner.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- [U-13C]glucose, [13C5]glutamine
- Keywords
- Cell metabolic tracing, Leukemic lymphocytes, Fuel preference
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[U-13C]glucoseOther
[U-13C]glucose will be administered as a bolus of 8 g (grams) over 10 minutes followed by 8 g/hour continuous infusion over 2 hours . This infusion rate will allow glucose tracer to reach sufficient enrichment without causing significant metabolic perturbation such as hyperglycemia.
[13C5]glutamineOther
6mg/kg of body weight of [13C5]glutamine will be administered as a bolus over 10 minutes (± 1 minute) followed by 6mg/kg/hr body weight continuous infusion for 2 hours through a peripheral IV catheter/line. This infusion rate will allow glutamine tracer to reach sufficient enrichment without causing significant metabolic perturbation such as hyperglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Healthy volunteers | Healthy volunteers are defined as people without a history of cancer Receives: Other: [U-13C]glucose | |
| Group B subset-1: Treatment naïve CLL(Chronic Lymphocytic Leukemia) patients with low disease burden | Participants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0. Receives: Other: [13C5]glutamine | |
| Group B subset-2: Treatment naïve CLL patients with low disease burden | Participants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0. Receives: Other: [U-13C]glucose | |
| Group C:Treatment naïve CLL patients with high systemic disease burden | Treatment naïve CLL patients with high systemic disease burden Receives: Other: [U-13C]glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of [U-13C]glucose incorporation into metabolites in normal and leukemic lymphocytes: Liquid chromatography-mass spectrometry (LCMS) pharmacokinetic analysis
It will reveal how CLL cells utilize glucose compared to non-leukemic lymphocytes and how this changes with different disease burden and site of disease. Participants will be on overnight fasting.
Measured: up to 2 hours (± 5 minutes)
Amount of [U-13C15N]L-glutamine incorporation into metabolites in normal and leukemic lymphocytes: LCMS pharmacokinetic analysis
It will reveal how CLL cells utilize glutamine compared to non-leukemic lymphocytes and how this changes with different disease burden and site of disease. Participants will be on overnight fasting.
Measured: up to 2 hours (± 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start13 Jun 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Fletcher, MD, Principal investigator, School of Medicine and Public Health, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785989
- Sponsor's protocol ID
- UW20062
- Other IDs
- MSN240796, SMPH/MEDICINE/HEM-ONC, A534260, Protocol Version 10/19/2022, 2020-1008
- Status last verified
- Oct 2025
- First submitted
- 25 Feb 2021
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profiling of Leukemic Cells Through Isotope Tracing in Patients With CLL
- ClinicalTrials.gov ID
- NCT04785989
- Acronym / sponsor ID
- UW20062
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Cell metabolic tracing, Leukemic lymphocytes, Fuel preference
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Mar 2021 (actual)
- 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.
Metabolic reprogramming has been identified as a hallmark of cancer. Almost a century after Otto Warburg initially discovered increased glycolytic activity in tumor tissue ("Warburg effect"), therapeutic targeting of cancer metabolism has become a field of intense research effort in cancer biology.
A growing appreciation of metabolic heterogeneity and complexity is currently reshaping investigators "simplistic" understanding of metabolic reprogramming in cancer. Discovering metabolic vulnerabilities as new treatment targets for cancer requires systematic dissection of metabolic dependencies, fuel preferences, and underlying mechanisms in the specific physiological context. However, today's data on cancer cell metabolic signatures and heterogeneity in their physiological habitat of the human organism is sparse to non-existent representing a critical knowledge gap in designing effective metabolic therapies. Here, the investigators propose a "top-down" approach studying cancer cell metabolism in patients followed by mechanistic in-depth studies in cell culture and animal models to define metabolic vulnerabilities.
Investigators will develop a metabolic tracing method to quantitatively characterize metabolic signatures and fuel preferences of leukemic lymphocytes in patients with chronic lymphocytic leukemia (CLL). Isotopic metabolic tracers are nutrients that are chemically identical to the native nutrient. Incorporated stable, non-radioactive isotopes allow investigators to follow their metabolic fate by monitoring conversion of tracer nutrients into downstream metabolites using cutting-edge metabolomics analysis. Using this method, investigators propose to test the hypothesis that leukemic lymphocytes show tissue-specific metabolic preferences that differ from non-leukemic lymphocytes and that ex vivo in-plasma labeling represents a useful model for assaying metabolic activity in leukemic cells in a patient-specific manner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Healthy volunteers | – | Other: [U-13C]glucoseHealthy volunteers are defined as people without a history of cancer |
| Group B subset-1: Treatment naïve CLL(Chronic Lymphocytic Leukemia) patients with low disease burden | – | Other: [13C5]glutamineParticipants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0. |
| Group B subset-2: Treatment naïve CLL patients with low disease burden | – | Other: [U-13C]glucoseParticipants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0. |
| Group C:Treatment naïve CLL patients with high systemic disease burden | – | Other: [U-13C]glucoseTreatment naïve CLL patients with high systemic disease burden |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To meet the study aims sixteen (16) adult participants will be enrolled: four (4) healthy volunteers defined as people without a history of cancer, 8 patients with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0, and 4 patients with high disease burden CLL defined as having extensive infiltration of the bone marrow.
Key inclusion criteria (16 listed)
- Group A
- Adult (18 years of age or older)
- No previous history of cancer
- Routine history of normal blood counts and vital signs
- Documented Informed Consent
Key exclusion criteria (11 listed)
- For all participants
- Prisoners
- Psychiatric inpatients or people who are institutionalized
- Minor (Less than 18 years of age)
- History of diabetes
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 |
|---|---|---|
| [U-13C]glucose[U-13C]glucose will be administered as a bolus of 8 g (grams) over 10 minutes followed by 8 g/hour continuous infusion over 2 hours . This infusion rate will allow glucose tracer to reach sufficient enrichment without causing significant metabolic perturbation such as hyperglycemia. | Other | Group A: Healthy volunteers, Group B subset-2: Treatment naïve CLL patients with low disease burden, Group C:Treatment naïve CLL patients with high systemic disease burden |
| [13C5]glutamine6mg/kg of body weight of [13C5]glutamine will be administered as a bolus over 10 minutes (± 1 minute) followed by 6mg/kg/hr body weight continuous infusion for 2 hours through a peripheral IV catheter/line. This infusion rate will allow glutamine tracer to reach sufficient enrichment without causing significant metabolic perturbation such as hyperglycemia. | Other | Group B subset-1: Treatment naïve CLL(Chronic Lymphocytic Leukemia) patients with low disease burden |
Primary outcome
Amount of [U-13C]glucose incorporation into metabolites in normal and leukemic lymphocytes: Liquid chromatography-mass spectrometry (LCMS) pharmacokinetic analysis
Time frame: up to 2 hours (± 5 minutes)
It will reveal how CLL cells utilize glucose compared to non-leukemic lymphocytes and how this changes with different disease burden and site of disease. Participants will be on overnight fasting.
Amount of [U-13C15N]L-glutamine incorporation into metabolites in normal and leukemic lymphocytes: LCMS pharmacokinetic analysis
Time frame: up to 2 hours (± 5 minutes)
It will reveal how CLL cells utilize glutamine compared to non-leukemic lymphocytes and how this changes with different disease burden and site of disease. Participants will be on overnight fasting.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Christopher Fletcher, MD principal investigator
School of Medicine and Public Health, University of Wisconsin, Madison
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 Chronic Lymphocytic Leukemia, run by University of Wisconsin, Madison 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 16 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of [U-13C]glucose incorporation into metabolites in normal and leukemic lymphocytes: Liquid chromatography-mass spectrometry (LCMS) pharmacokinetic analysis (time frame: up to 2 hours (± 5 minutes)). The study lists 2 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 26 Nov 2025.