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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
No Placebo-Only Group
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.
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.
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 belowSelect...
I have never had cancer before.
Select...
I am 18 years old or older.
Select...
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.
Select...
My CLL is advanced, affecting my bone marrow and blood cell counts.
Select...
I have not received any treatment for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 hours (± 5 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours (± 5 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Validate ex vivo labeling model to assay metabolism
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,231 Previous Clinical Trials
3,199,869 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have never had cancer before.My CLL is advanced, affecting my bone marrow and blood cell counts.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.I have not received any treatment for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Healthy volunteers
- Group 2: Group B subset-2: Treatment naïve CLL patients with low disease burden
- Group 3: Group C:Treatment naïve CLL patients with high systemic disease burden
- Group 4: Group B subset-1: Treatment naïve CLL(Chronic Lymphocytic Leukemia) patients with low disease burden
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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