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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
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group Identifier:
First received: April 25, 2011
Last updated: April 26, 2011
Last verified: April 2011

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated 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


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01342679

Contact: Chikashi Yoshida, MD, PhD +81(0)29-240-7711
Contact: Hisashi Sakamaki, MD, PhD +81(0)3-3823-2101

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8677
Contact: Hisashi Sakamaki, MD, PhD    +81(0)3-3823-2101   
Sponsors and Collaborators
Kanto CML Study Group
Epidemiological and Clinical Research Information Network
Principal Investigator: Chikashi Yoshida, MD, PhD National Hospital Organization, Mito Medical Center
  More Information

No publications provided

Responsible Party: Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Identifier: NCT01342679     History of Changes
Other Study ID Numbers: KCSG-02
Study First Received: April 25, 2011
Last Updated: April 26, 2011
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms by Histologic Type
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on February 27, 2015