NCT06536452

Brief Summary

This study evaluates hematopoiesis to determine how MBL/CLL affected bone marrow responds to fight off infections in the body.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2016Nov 2028

Study Start

First participant enrolled

November 18, 2016

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

12 years

First QC Date

July 31, 2024

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Study Arms (1)

Observational

Patients undergo blood sample collection and bone marrow aspiration and biopsy and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-interventional study

Observational

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with MBL, patients with CLL ,and healthy subjects recruited through Mayo Clinic.

You may qualify if:

  • 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

You may not qualify if:

  • Anyone under 40
  • Healthy control subjects must not have a diagnosis of CLL or MBL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil E. Kay, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

November 18, 2016

Primary Completion (Estimated)

November 18, 2028

Study Completion (Estimated)

November 18, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations