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

Kanto CML Study Group1 site in 1 country40 target enrollmentJuly 2011

ConditionsLeukemia, Myelogenous, Chronic, BCR-ABL Positive Myelogenous Leukemia, Chronic, Chronic Phase

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Sponsor: Kanto CML Study Group
Enrollment: 40
Locations: 1
Primary Endpoint: Rate of complete molecular response (CMR) after treatment with dasatinib
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

TBD

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Kanto CML Study Group

Responsible Party

Principal Investigator

Takashi Kumagai

M.D, Ph.D

Kanto CML Study Group

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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)