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Trial Title:
Hematopoiesis in MBL and CLL Versus Healthy Age-Matched Control Subjects
NCT ID:
NCT06536452
Condition:
Chronic Lymphocytic Leukemia
Monoclonal B-Cell Lymphocytosis
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphocytosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
Summary:
This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds
to fight off infections in the body.
Detailed description:
PRIMARY OBJECTIVES:
I. Determine the cellular and mechanistic basis of bone marrow (BM) hematopoietic
dysfunction in untreated MBL and CLL patients.
II. Determine if MBL and CLL B cell derived cellular products directly alter the
differentiation and functional capacities of Hematopoietic Stem and Progenitor Cells
(HSPCs).
III. Utilize the Emu-Tcl1 transgenic mouse model to determine how MBL and CLL
patient-derived cellular products alter BM hematopoiesis.
OUTLINE: This is an observational study.
Patients undergo blood sample collection and bone marrow aspiration and biopsy and have
their medical records reviewed on study.
Criteria for eligibility:
Study pop:
Patients with MBL, patients with CLL ,and healthy subjects recruited through Mayo Clinic.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Subjects in the CLL cohort who are eligible for these studies will have a clinically
established diagnosis of CLL as assessed by flow cytometry and will include subjects
who
- Remain untreated
- Are currently being treated
- Who have already been treated
- Subjects in the MBL cohort will have a clinically established diagnosis of MBL
- Healthy age-matched control subjects
- Healthy younger control subjects aged > 40 years
Exclusion Criteria:
- Anyone under 40
- Healthy control subjects must not have a diagnosis of CLL or MBL
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Neil E. Kay, M.D.
Email:
Principal Investigator
Start date:
November 18, 2016
Completion date:
November 18, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06536452
https://www.mayo.edu/research/clinical-trials
