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Metabolic Profiling for Chronic Lymphocytic Leukemia

N/A
Recruiting
Led By Christopher Fletcher, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No previous history of cancer
Adult (18 years of age or older)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 hours (± 5 minutes)
Awards & highlights

Study Summary

This trial will help researchers develop a method to study cancer cell metabolism and fuel preferences in patients with chronic lymphocytic leukemia.

Who is the study for?
This trial is for adults over 18 with or without Chronic Lymphocytic Leukemia (CLL). Group A includes healthy adults, Group B includes those newly diagnosed with low-burden CLL, and Group C has individuals with high-burden CLL affecting bone marrow. All must consent to participate.Check my eligibility
What is being tested?
The study tests how leukemic cells process nutrients differently from normal cells by using special forms of glucose and glutamine ([13C5]glutamine, [U-13C]glucose) that can be tracked in the body to understand cancer cell metabolism.See study design
What are the potential side effects?
Since this trial focuses on metabolic profiling rather than treatment, side effects are minimal but may include discomfort at injection sites or allergic reactions to tracers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had cancer before.
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I am 18 years old or older.
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I have CLL with a low disease burden, meaning my blood counts are near normal and there's no significant swelling of lymph nodes, spleen, or liver.
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My CLL is advanced, affecting my bone marrow and blood cell counts.
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I have not received any treatment for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours (± 5 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours (± 5 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount of [U-13C15N]L-glutamine incorporation into metabolites in normal and leukemic lymphocytes: LCMS pharmacokinetic analysis
Amount of [U-13C]glucose incorporation into metabolites in normal and leukemic lymphocytes: Liquid chromatography-mass spectrometry (LCMS) pharmacokinetic analysis
Other outcome measures
Validate ex vivo labeling model to assay metabolism

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group C:Treatment naïve CLL patients with high systemic disease burdenExperimental Treatment1 Intervention
Treatment naïve CLL patients with high systemic disease burden
Group II: Group B subset-2: Treatment naïve CLL patients with low disease burdenExperimental Treatment1 Intervention
Participants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0.
Group III: Group B subset-1: Treatment naïve CLL(Chronic Lymphocytic Leukemia) patients with low disease burdenExperimental Treatment1 Intervention
Participants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0.
Group IV: Group A: Healthy volunteersExperimental Treatment1 Intervention
Healthy volunteers are defined as people without a history of cancer

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,186 Previous Clinical Trials
3,169,431 Total Patients Enrolled
Christopher Fletcher, MDPrincipal InvestigatorSchool of Medicine and Public Health, University of Wisconsin, Madison
1 Previous Clinical Trials
26 Total Patients Enrolled

Media Library

[U-13C]glucose Clinical Trial Eligibility Overview. Trial Name: NCT04785989 — N/A
Chronic Lymphocytic Leukemia Research Study Groups: 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, Group B subset-1: Treatment naïve CLL(Chronic Lymphocytic Leukemia) patients with low disease burden
Chronic Lymphocytic Leukemia Clinical Trial 2023: [U-13C]glucose Highlights & Side Effects. Trial Name: NCT04785989 — N/A
[U-13C]glucose 2023 Treatment Timeline for Medical Study. Trial Name: NCT04785989 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort participating in this clinical trial?

"Affirmative. The clinicaltrials.gov web page reveals that this medical study, which was originally posted on June 13th 2022, is proactively recruiting volunteers. 16 participants need to be enrolled at 1 centre."

Answered by AI

Are there any vacancies on this research initiative?

"Per the clinicaltrials.gov entries, this research is actively seeking eligible participants. It was first advertised on June 13th of 2022 and has had its most recent update on June 15th of that same year."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
In Vivo Metabolic Profiling of CLL (Chronic Lymphocytic Leukemia)
2022. "In Vivo Metabolic Profiling of CLL (Chronic Lymphocytic Leukemia)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04785989.
All > Cll > Chronic Lymphocytic Leukemia
~3 spots leftby Oct 2024
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