A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

Chronic Myeloid Leukemia Clinical Trial

— CMR-CML  

Official title:

A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342679
• Other study ID #: KCSG-02
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2011
• Last updated: September 14, 2015
• Start date: April 2011
• Est. completion date: September 2014

Study information

• Verified date: April 2011
• Source: Kanto CML Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Chronic Myeloid Leukemia in the Chronic Phase

• 20 years old over

• ECOG performance status (PS) score 0-2

• Patients for major molecular response (MMR) with no CMR

• 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 within 6 months

• have an Angina within 3 months

• have a Congestive heart failure within 3 months

• have a suspected congenital QT syndrome

• 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

• Prior treatment with dasatinib

• Subjects with T315I, F317L and V299L BCR-ABL point mutations

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• dasatinib
100mg QD

Locations

Country	Name	City	State
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Bunkyo-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Kanto CML Study Group	Epidemiological and Clinical Research Information Network

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		at 12 months	No
Secondary	Dasatinib of dose intensity		at 12 months	No
Secondary	Expansions rate of large granular lymphocyte		at 12 months	No
Secondary	Progression free survival		at 12 months	No
Secondary	Number of Participants with Adverse Events		at 12 months	Yes