Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Kanto CML Study Group.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Takashi Kumagai, Kanto CML Study Group Identifier:
First received: September 18, 2011
Last updated: November 2, 2011
Last verified: November 2011
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.

Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelogenous Leukemia, Chronic, Chronic Phase

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

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: 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.

Secondary Outcome Measures:
  • 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 ]

Biospecimen 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.

Estimated Enrollment: 40
Study Start Date: July 2011

Ages Eligible for Study:   20 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan

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
  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: NCT01464411

Contact: Takashi Kumagai, M.D, Ph.D 81-428-22-3191
Contact: Hisashi Sakamaki, M.D, Ph.D 81-3-3823-2101

Kanto CML Study Group Recruiting
Tokyo, Japan
Contact: Hisashi Sakamaki, M.D, Ph.D    81-3-3823-2101   
Contact: Takashi Kumagai, M.D, Ph.D    81-428-22-3191   
Principal Investigator: Takashi Kumagai, M.D, Ph.D         
Sponsors and Collaborators
Kanto CML Study Group
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Takashi Kumagai, M.D, Ph.D, Kanto CML Study Group Identifier: NCT01464411     History of Changes
Other Study ID Numbers: KCSG-03
Study First Received: September 18, 2011
Last Updated: November 2, 2011

Keywords provided by Kanto CML Study Group:
chronic myelogenous leukemia
chronic phase
Phase II

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017