Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan (D-First)

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. Identifier: NCT01464411
Recruitment Status : Unknown
Verified November 2011 by Takashi Kumagai, Kanto CML Study Group.
Recruitment status was:  Recruiting
First Posted : November 3, 2011
Last Update Posted : November 3, 2011
Information provided by (Responsible Party):
Takashi Kumagai, Kanto CML Study Group

September 18, 2011
November 3, 2011
November 3, 2011
July 2011
Not Provided
Rate of complete molecular response (CMR) after treatment with dasatinib [ Time Frame: by 18 months ]
The rate(%) of patients who achieve complete molecular response (CMR) by 18 months after the dasatinib therapy will be measured to evaluate the efficiency of dasatinib.
Same as current
No Changes Posted
  • complete molecular response (CMR) [ Time Frame: by 3,6,12,24, 36 months ]
  • Major Molecular Response(MMR) [ Time Frame: by 3,6,12,18,24,36 months ]
  • Complete Cytogenetic Response(CCyR) [ Time Frame: by 6,12 months ]
  • Expansions rate of large granular lymphocyte [ Time Frame: by 12 months ]
  • Progression free survival [ Time Frame: at 36 months ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: by 36 months ]
Same as current
Not Provided
Not Provided
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.
Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA

Copy numbers of bcr-abl mRNA in patients with dasatinib treatment will be measured by real-time RT-PCR to evaluate the efficiency of dasatinib.

For patients resistant to dasatinib therapy, DNA mutation analysis of the bcr-abl gene associated with drug-resistancy will be performed.

Probability Sample
Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelogenous Leukemia, Chronic, Chronic Phase
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
Not Provided

Inclusion Criteria:

  • Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
  • 20 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
  • The case of Pleural effusion clearly
  • Patients with complications or a history of severe or uncontrolled cardiovascular failure following

    • have a Myocardial infarction whithin 6 months
    • have an Angina within 3 months
    • have a Congestive heart failure within 3 months
    • 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
Sexes Eligible for Study: All
20 Months and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Takashi Kumagai, Kanto CML Study Group
Kanto CML Study Group
Not Provided
Not Provided
Kanto CML Study Group
November 2011