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Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

Sponsor
Shimousa Hematology Study Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT01627132
Collaborator
Epidemiological and Clinical Research Information Network (Other)
50
Enrollment
1
Location
1
Arm
83
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
Study Start Date :
Feb 1, 2012
Anticipated Primary Completion Date :
Feb 1, 2017
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: dasatinib

Drug: Dasatinib
100mg QD
Other Names:
  • BMS-354825

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib. [at 12 months]

    Secondary Outcome Measures

    1. Rate of complete molecular remission that will be sustained after dasatinib rechallenge. [at 12 months]

    Eligibility Criteria

    Criteria

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

    • Chronic Myeloid Leukemia in the Chronic Phase.

    • Patients with BCR-ABL-negative checks.

    • 15 years old over.

    • ECOG performance status (PS) score 0-2.

    • Adequate organ function (hepatic, renal and lung).

    • Signed written informed consent.

    Exclusion Criteria:

    • A case with the double cancer of the activity.

    • Women who are pregnant or breastfeeding.

    • Patients with complications or a history of severe.

    • Patients with mutation of T315I、F317L、V299L.

    • Patients with additional chromosome abnormalities.

    • The case of Pleural effusion with poor control.

    • Patients with a history of hematopoietic stem cell transplantation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nippon Medical School Sendagi 1-1-5 Bunkyo-ku,Tokyo Japan 113-8603

    Sponsors and Collaborators

    • Shimousa Hematology Study Group
    • Epidemiological and Clinical Research Information Network

    Investigators

    • Principal Investigator: Koiti Inokuchi, Nippon Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Koiti Inokuchi,MD,PhD., Nippon Medical School, Shimousa Hematology Study Group
    ClinicalTrials.gov Identifier:
    NCT01627132
    Other Study ID Numbers:
    • SHSG-01
    First Posted:
    Jun 25, 2012
    Last Update Posted:
    Jun 25, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Dasatinib

    Study Results

    No Results Posted as of Jun 25, 2012