Hematopoiesis in MBL and CLL Versus Hea… | Clinical Trial

Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Monoclonal B-Cell Lymphocytosis Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Neil E. Kay, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

Effects of MBL on bone marrow function

Time frame: Baseline

Samples 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 function

Time frame: Baseline

Samples 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2028
Study completion: 2028
First posted: Aug 5, 2024
Registry last updated: Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not Yet Recruiting