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Korean Post-marketing Surveillance for Sprycel®

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01464047
Collaborator
(none)
670
Enrollment
1
Location
46
Duration (Months)
14.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    670 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Korean Post-marketing Surveillance for Sprycel®
    Study Start Date :
    Oct 1, 2011
    Actual Primary Completion Date :
    Aug 1, 2015
    Actual Study Completion Date :
    Aug 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with CML or Ph+ ALL

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events occurrence [30 days after last dose of study drug]

    Secondary Outcome Measures

    1. Improvement in hematologic response [4 weeks after registration]

      The number and percentage of subjects who satisfy each criterion of hematologic responses (Complete/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value

    2. Improvement in cytogenetic response [12 weeks after registration]

      The number and percentage of subjects who satisfy each criterion of cytogenetic responses (Complete/Partial/Minor/Minimal/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value

    3. Overall efficacy assessment by investigator's discretion [4 weeks after registration]

      Based on demographic factors, treatment factors like medical history and concomitant medication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase

    • Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib

    • Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy

    Exclusion Criteria:
    • According to Warning/Caution in local label

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Seoul Korea, Republic of 110-756

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01464047
    Other Study ID Numbers:
    • CA180-370
    First Posted:
    Nov 3, 2011
    Last Update Posted:
    Apr 27, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myelomonocytic, Chronic

    Study Results

    No Results Posted as of Apr 27, 2016