B-type Chronic Lymphocytic Leukemia (B-CLL) Subgroups: Maturation Stage and Gene Expression

Sponsor
Northwell Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01030913
Collaborator
(none)
1,248
1
278
4.5

Study Details

Study Description

Brief Summary

B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western world. It is a disease that occurs primarily in aging individuals and occurs more frequently in males than females. Although B-CLL was considered a homogeneous condition, recent studies by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.

These sub-groups can be identified by either the presence or the absence of mutations in antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody genes low percentage CD38) follow strikingly clinically different courses. For example, the unmutated/CD38+ group experiences a much more aggressive disease and these patients almost invariably die much sooner than the cases in the other group. In addition, the patients in the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally, surprisingly there is a much higher representation of males in the poor outcome unmutated CD38 group than in the better outcome group. The reasons for these differences in clinical outcome and gender bias are unknown.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1248 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    B-CLL Subgroups: Maturation Stage and Gene Expression
    Study Start Date :
    Dec 1, 1999
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia

    Outcome Measures

    Primary Outcome Measures

    1. differentiating B-CLL cells by the presence or absence of mutations in antibody genes and/or by the percentage of cells expressing CD38 and the difference in clinical disease course and outcome for each group [follow through the clinical disease course for each group]

    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 able to contribute the required amount of blood without compromising their well being,

    • Participants must be willing to be contacted again in the future for additional blood drawing.

    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:
    NCT01030913
    Other Study ID Numbers:
    • 04-057
    First Posted:
    Dec 14, 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 8, 2022