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B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging

Sponsor
Northwell Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01028430
Collaborator
(none)
1,000
Enrollment
1
Location
296
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for ~25% of all leukemia's (1). This disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence before the age of 50 is quite unusual. This increase in occurrence with age is not unique to B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g., non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of B-CLL. Thus, the ratio of men: women is ~2:1 and the prevalence is increased in Caucasians. The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and this does not increase with immigration to the West. DNA sequence analyses performed in our laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig V gene characteristics. These include the use of selected genes, the association of these genes with certain D and JH gene segments that code for unique CDR3 motifs, and the occasional occurrence of highly similar VHDJH + VLJL pairs. In ~50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the VH gene family used by the B-CLL cell.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging
    Study Start Date :
    Jul 1, 1998
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia

    Outcome Measures

    Primary Outcome Measures

    1. expression of cell surface antigens HLA-DR and CD38+ markers in B-CLL cells compared to normal B-lymphocytes [samples will be taken at the beginning, week 2, 4,6,8,12,and 24 (for blood), and bone marrow samples at weeks 2 and 6.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 years of age Patients must be willing to be contacted in the future
    Exclusion Criteria:
    • Patients who are known to be anemic, with a hemoglobin <8 PAtients who are known to be infected with HIV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Feinstein Institute for Medical Research Manhasset New York United States 11030

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    • Principal Investigator: Nicholas Chiorazzi, MD, Northwell Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicholas Chiorazzi, Investigator, The Feinstein Institute for Medical Research, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT01028430
    Other Study ID Numbers:
    • 04-046
    First Posted:
    Dec 9, 2009
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by Nicholas Chiorazzi, Investigator, The Feinstein Institute for Medical Research, Northwell Health
    Chronic Lymphocytic Leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Jul 8, 2022