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

This study is currently recruiting participants.
Verified November 2011 by Kanto CML Study Group
Sponsor:
Information provided by (Responsible Party):
Takashi Kumagai, Kanto CML Study Group
ClinicalTrials.gov Identifier:
NCT01464411
First received: September 18, 2011
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
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:

Drug Information available for: Dasatinib
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Major Molecular Response(MMR) [ Time Frame: by 3,6,12,18,24,36 months ] [ Designated as safety issue: No ]
  • Complete Cytogenetic Response(CCyR) [ Time Frame: by 6,12 months ] [ Designated as safety issue: No ]
  • Expansions rate of large granular lymphocyte [ Time Frame: by 12 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: at 36 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: by 36 months ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   20 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464411

Contacts
Contact: Takashi Kumagai, M.D, Ph.D 81-428-22-3191 kumamed1_2001@yahoo.co.jp
Contact: Hisashi Sakamaki, M.D, Ph.D 81-3-3823-2101 sakamaki-h@cick.jp

Locations
Japan
Kanto CML Study Group Recruiting
Tokyo, Japan
Contact: Hisashi Sakamaki, M.D, Ph.D     81-3-3823-2101     sakamaki-h@cick.jp    
Contact: Takashi Kumagai, M.D, Ph.D     81-428-22-3191     kumamed1_2001@yahoo.co.jp    
Principal Investigator: Takashi Kumagai, M.D, Ph.D            
Sponsors and Collaborators
Kanto CML Study Group
  More Information

No publications provided

Responsible Party: Takashi Kumagai, M.D, Ph.D, Kanto CML Study Group
ClinicalTrials.gov Identifier: NCT01464411     History of Changes
Other Study ID Numbers: KCSG-03
Study First Received: September 18, 2011
Last Updated: November 2, 2011
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
 Hematologic Diseases
Disease Attributes
Pathologic Processes
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013