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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Kanto CML Study Group.
Recruitment status was  Recruiting
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

September 18, 2011
November 2, 2011
July 2011
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01464411 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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
Both
20 Months and older
No
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
Japan
 
NCT01464411
KCSG-03
Yes
Takashi Kumagai, Kanto CML Study Group
Kanto CML Study Group
Not Provided
Not Provided
Kanto CML Study Group
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP