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A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib (CMR-CML)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342679
First Posted: April 27, 2011
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group
  Purpose
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia

Condition Intervention Phase
Chronic Myeloid Leukemia Drug: dasatinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

Resource links provided by NLM:


Further study details as provided by Kanto CML Study Group:

Primary Outcome Measures:
  • Rate of complete molecular response (CMR) after treatment with dasatinib [ Time Frame: at 12 months ]

Secondary Outcome Measures:
  • Dasatinib of dose intensity [ Time Frame: at 12 months ]
  • Expansions rate of large granular lymphocyte [ Time Frame: at 12 months ]
  • Progression free survival [ Time Frame: at 12 months ]
  • Number of Participants with Adverse Events [ Time Frame: at 12 months ]

Enrollment: 21
Study Start Date: April 2011
Study Completion Date: September 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dasatinib Drug: dasatinib
100mg QD
Other Name: BMS-354825

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Myeloid Leukemia in the Chronic Phase
  • 20 years old over
  • ECOG performance status (PS) score 0-2
  • Patients for major molecular response (MMR) with no CMR
  • 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
  • The case of Pleural effusion clearly
  • Patients with complications or a history of severe or uncontrolled cardiovascular failure following

    • have a Myocardial infarction within 6 months
    • have an Angina within 3 months
    • have a Congestive heart failure within 3 months
    • have a suspected congenital QT syndrome
    • have a QTc interval of more than 450msec at baseline
  • A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
  • Prior treatment with dasatinib
  • Subjects with T315I, F317L and V299L BCR-ABL point mutations
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342679


Locations
Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
Sponsors and Collaborators
Kanto CML Study Group
Epidemiological and Clinical Research Information Network
Investigators
Principal Investigator: Chikashi Yoshida, MD, PhD National Hospital Organization, Mito Medical Center
  More Information

Responsible Party: Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
ClinicalTrials.gov Identifier: NCT01342679     History of Changes
Other Study ID Numbers: KCSG-02
First Submitted: April 25, 2011
First Posted: April 27, 2011
Last Update Posted: September 15, 2015
Last Verified: April 2011

Keywords provided by Kanto CML Study Group:
chronic myeloid leukemia
dasatinib
complete molecular response

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action