Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan

• Conditions: Myelogenous Leukemia, Chronic, Chronic Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

• Registration Number: NCT01464411
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-18
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-02
• Last Update Submitted: 2011-11-02
• Study First Posted: 2011-11-03
• Last Update Posted: 2011-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete molecular response (CMR) after treatment with dasatinib	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

Name	Time	Method
Complete Cytogenetic Response(CCyR)	by 6,12 months
Expansions rate of large granular lymphocyte	by 12 months
Progression free survival	at 36 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	by 36 months
complete molecular response (CMR)	by 3,6,12,24, 36 months
Major Molecular Response(MMR)	by 3,6,12,18,24,36 months

Trial Locations

Locations (1)

Kanto CML Study Group; 🇯🇵 Tokyo, Japan