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Understanding Chronic Lymphocytic Leukemia

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04028531
Collaborator
National Cancer Institute (NCI) (NIH)
2,750
Enrollment
1
Location
324
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia, for the potential development of more effective therapies for this disease.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2750 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Understanding Chronic Lymphocytic Leukemia
    Actual Study Start Date :
    Sep 29, 1999
    Anticipated Primary Completion Date :
    Sep 29, 2024
    Anticipated Study Completion Date :
    Sep 29, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Sample Collection

    Blood tests required for assessment Specimens and data will also be collected from outside sites Clinical data from patients with Chronic Lymphocytic Leukemia will be gathered into a database at Dana Farber Cancer Institute

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of novel genomic prognostic markers in Chronic Lymphocytic Leukemia [20 years]

      Exploratory science to better understand Chronic Lymphocytic Leukemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • New and existing patients seen for treatment of monoclonal B-cell lymphocytosis

    • Any low grade lymphoproliferative disorder

    • Chronic Lymphocytic Leukemia in the Dana Farber Cancer Institute Hematologic Oncology Clinic or elsewhere

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana Farber Cancer Institute Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jennifer Brown, MD,PhD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jennifer R. Brown, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT04028531
    Other Study ID Numbers:
    • 99-224
    • R01CA213442-01A1
    First Posted:
    Jul 22, 2019
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jennifer R. Brown, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
    Chronic Lymphocytic Leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Aug 2, 2022