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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
April 25, 2011
April 27, 2011
September 15, 2015
April 2011
March 2013   (Final data collection date for primary outcome measure)
Rate of complete molecular response (CMR) after treatment with dasatinib [ Time Frame: at 12 months ]
Same as current
Complete list of historical versions of study NCT01342679 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Myeloid Leukemia
Drug: dasatinib
100mg QD
Other Name: BMS-354825
Experimental: dasatinib
Intervention: Drug: dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2014
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01342679
KCSG-02
Yes
Not Provided
Not Provided
Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Kanto CML Study Group
Epidemiological and Clinical Research Information Network
Principal Investigator: Chikashi Yoshida, MD, PhD National Hospital Organization, Mito Medical Center
Kanto CML Study Group
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP