Chronic Lymphocytic LeukemiaNCT06536452
Hematopoiesis in MBL and CLL Versus Healthy Age-Matched Control Subjects
An observational study of Chronic Lymphocytic Leukemia and Monoclonal B-Cell Lymphocytosis, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Monoclonal B-Cell Lymphocytosis
- What is being tested?
- Non-Interventional Study
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2016to 18 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with MBL, patients with CLL ,and healthy subjects recruited through Mayo Clinic.
Who may be able to join
- 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
Who cannot join
- Anyone under 40
- Healthy control subjects must not have a diagnosis of CLL or MBL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Neil E. Kay, M.D.
About this study
Official title: Hematopoiesis in Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) Versus Healthy Age-Matched Control Subjects
This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Non-Interventional Study
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood sample collection and bone marrow aspiration and biopsy and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of MBL on bone marrow function
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.
Measured: Baseline
Effects of CLL on bone marrow function
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start18 Nov 2016
- Primary completion18 Nov 2028 (estimated)
- Study completion18 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil E. Kay, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536452
- Sponsor's protocol ID
- 16-006204
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoiesis in Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) Versus Healthy Age-Matched Control Subjects
- ClinicalTrials.gov ID
- NCT06536452
- Acronym / sponsor ID
- 16-006204
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 18 Nov 2028 (estimated)
- Study completion
- 18 Nov 2028 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo blood sample collection and bone marrow aspiration and biopsy and have their medical records reviewed on study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MBL, patients with CLL ,and healthy subjects recruited through Mayo Clinic.
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- Anyone under 40
- Healthy control subjects must not have a diagnosis of CLL or MBL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil E. Kay, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Monoclonal B-Cell Lymphocytosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of MBL on bone marrow function (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.