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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Kanto CML Study Group.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group
ClinicalTrials.gov Identifier:
NCT01342679
First received: April 25, 2011
Last updated: April 26, 2011
Last verified: April 2011
History of Changes

April 25, 2011
April 26, 2011
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Expansions rate of large granular lymphocyte [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Not yet recruiting
30
April 2013
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
Both
20 Years and older
No
Contact: Chikashi Yoshida, MD, PhD +81(0)29-240-7711 c.yoshida.d@mn.hosp.go.jp
Contact: Hisashi Sakamaki, MD, PhD +81(0)3-3823-2101 sakamaki-h@cick.jp
Japan
 
NCT01342679
KCSG-02
Yes
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