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

November 2, 2011 updated by: Takashi Kumagai, Kanto CML Study Group

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hisashi Sakamaki, M.D, Ph.D
  • Phone Number: 81-3-3823-2101
  • Email: sakamaki-h@cick.jp

Study Locations

  • Japan
      • Tokyo, Japan
        • Recruiting
        • Kanto CML Study Group
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Kumagai, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed chronic-phase chronic myelogenous leukemia in Japan

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
by 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanto CML Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Study Registration Dates

First Submitted

September 18, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 3, 2011

Last Update Submitted That Met QC Criteria

November 2, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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