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Hematopoiesis in MBL and CLL Versus Healthy Age-Matched Control Subjects

Hematopoiesis in Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) Versus Healthy Age-Matched Control Subjects

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06536452
Enrollment
50
Registered
2024-08-05
Start date
2016-11-18
Completion date
2028-11-18
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Monoclonal B-Cell Lymphocytosis

Brief 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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effects of MBL on bone marrow functionBaselineSamples collected from healthy participants and participants with MBL will be compared for differences in bone marrow function (i.e., ability to fight off infection). Results will be descriptive. With participant permission, samples will be stored for future research use.
Effects of CLL on bone marrow functionBaselineSamples collected from healthy participants and participants with CLL will be compared for differences in bone marrow function (i.e., ability to fight off infection). Results will be descriptive. With participant permission, samples will be stored for future research use.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNeil E. Kay, M.D.

Mayo Clinic in Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026