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

NCT ID: NCT06536452

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-18

Study Completion Date

2026-11-18

Brief Summary

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This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.

Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia Monoclonal B-Cell Lymphocytosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational

Patients undergo blood sample collection and bone marrow aspiration and biopsy and have their medical records reviewed on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil E. Kay, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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NCI-2024-00996

Identifier Type: REGISTRY

Identifier Source: secondary_id

16-006204

Identifier Type: OTHER

Identifier Source: secondary_id

16-006204

Identifier Type: -

Identifier Source: org_study_id

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