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

Leukemia, Myelogenous, Chronic, BCR-ABL Positive Clinical Trial

— D-First  

Official title:

Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01464411
• Other study ID #: KCSG-03
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2011
• Last updated: November 2, 2011
• Start date: July 2011

Study information

• Verified date: November 2011
• Source: Kanto CML Study Group
• Contact: Takashi Kumagai, M.D, Ph.D
• Phone: 81-428-22-3191
• Email: kumamed1_2001[@]yahoo.co.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Months and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Japan	Kanto CML Study Group	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kanto CML Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete molecular response (CMR) after treatment with dasatinib	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.	by 18 months	No
Secondary	complete molecular response (CMR)		by 3,6,12,24, 36 months	No
Secondary	Major Molecular Response(MMR)		by 3,6,12,18,24,36 months	No
Secondary	Complete Cytogenetic Response(CCyR)		by 6,12 months	No
Secondary	Expansions rate of large granular lymphocyte		by 12 months	No
Secondary	Progression free survival		at 36 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		by 36 months	No