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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Takashi Kumagai, Kanto CML Study Group

Brief Summary:
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 or disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelogenous Leukemia, Chronic, Chronic Phase

Study Type : Observational
Estimated Enrollment : 40 participants
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
Study Start Date : July 2011





Primary Outcome Measures :
  1. 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 :
  1. complete molecular response (CMR) [ Time Frame: by 3,6,12,24, 36 months ]
  2. Major Molecular Response(MMR) [ Time Frame: by 3,6,12,18,24,36 months ]
  3. Complete Cytogenetic Response(CCyR) [ Time Frame: by 6,12 months ]
  4. Expansions rate of large granular lymphocyte [ Time Frame: by 12 months ]
  5. Progression free survival [ Time Frame: at 36 months ]
  6. 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.



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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: November 2011

Keywords provided by Takashi Kumagai, 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
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action