Evaluating bone marrow function in patients with CLL and MBL compared to healthy individuals
Hematopoiesis in Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) Versus Healthy Age-Matched Control Subjects
Mayo Clinic · NCT06536452
This study is trying to see how bone marrow function is different in people with Chronic Lymphocytic Leukemia (CLL) and Monoclonal B-Cell Lymphocytosis (MBL) compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06536452 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how bone marrow hematopoiesis is affected in patients with Chronic Lymphocytic Leukemia (CLL) and Monoclonal B-Cell Lymphocytosis (MBL). The study will analyze the cellular and mechanistic basis of hematopoietic dysfunction in untreated patients and investigate how B cell-derived products from these patients influence the differentiation and function of Hematopoietic Stem and Progenitor Cells (HSPCs). Utilizing a transgenic mouse model, researchers will further explore the impact of patient-derived cellular products on bone marrow hematopoiesis. Participants will undergo blood sample collection and bone marrow aspiration, with their medical records reviewed for comprehensive analysis.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with CLL or MBL, as well as healthy age-matched controls.
Not a fit: Patients under 40 years old or those with a diagnosis of CLL or MBL who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of hematopoietic dysfunction in CLL and MBL, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies have explored hematopoiesis in similar contexts, but this specific approach using patient-derived products in a transgenic model is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Neil E. Kay, M.D. — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Lymphocytic Leukemia, Monoclonal B-Cell Lymphocytosis