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

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Monoclonal B-Cell Lymphocytosis
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06536452
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2016-11-18
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-11-18
• Study Completion: 2026-11-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection and bone marrow aspiration and biopsy and have their medical records reviewed on study.

Primary Outcome Measures

Name	Time	Method
Effects of CLL on bone marrow function	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.
Effects of MBL on bone marrow function	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States