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Natural History Study of Patients With Chronic Myelogenous Leukemia

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00429910
Collaborator
National Cancer Institute (NCI) (NIH)
48
Enrollment
1
Location
31
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help doctors learn more about the disease and find better methods of treatment and on-going care.

PURPOSE: This natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    OBJECTIVES:

    • Determine the impact of current procedures for diagnosis, management, and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia (CML).

    • Determine the natural history of patients with CML who achieve response to imatinib mesylate.

    • Determine the health perceptions, symptoms, insurance issues, and work issues of these patients.

    • Determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients.

    • Determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients.

    OUTLINE: This is a longitudinal, prospective, cohort study.

    Patients complete quality of life, functional status, medical and treatment history, and medication questionnaires at baseline and then every 6 months for 5 years.

    Blood samples are collected at baseline and then every 6 months for 5 years. Specimens may be examined in the future in gene array studies and mutation analyses.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    48 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Chronic Myeloid Leukemia (CML) Cohort
    Study Start Date :
    Feb 1, 2003
    Actual Primary Completion Date :
    Sep 1, 2005
    Actual Study Completion Date :
    Sep 1, 2005

    Outcome Measures

    Primary Outcome Measures

    1. Impact of current procedures for diagnosis, management, and follow-up on disease status [5 years]

    2. Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate [5 years]

    3. Health perceptions, symptoms, insurance issues, and work issues [5 years]

    4. Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness [5 years]

    5. Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Age 18 years and over Diagnosis within one year of enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts United States 02115

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: Jerome Ritz, MD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jerome Ritz, MD, Jerome M.Ritz MD, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00429910
    Other Study ID Numbers:
    • 03-015
    • P30CA006516
    • CDR0000352370
    First Posted:
    Feb 1, 2007
    Last Update Posted:
    Jan 2, 2017
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jerome Ritz, MD, Jerome M.Ritz MD, Dana-Farber Cancer Institute
    accelerated phase chronic myelogenous leukemia
    blastic phase chronic myelogenous leukemia
    chronic phase chronic myelogenous leukemia
    meningeal chronic myelogenous leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive

    Study Results

    No Results Posted as of Jan 2, 2017