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Recruiting NCT06536452

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

— Observational Chronic Lymphocytic Leukemia Monoclonal B-Cell Lymphocytosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Chronic Lymphocytic Leukemia, Monoclonal B-Cell Lymphocytosis. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Effects of MBL on bone marrow function [Time frame: Baseline]
  • Effects of CLL on bone marrow function [Time frame: Baseline]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06536452 · 16-006204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗