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A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib (CMR-CML)

Primary Purpose

Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
dasatinib
Sponsored by
Kanto CML Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring chronic myeloid leukemia, dasatinib, complete molecular response

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dasatinib

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dasatinib of dose intensity
Expansions rate of large granular lymphocyte
Progression free survival
Number of Participants with Adverse Events

Full Information

First Posted
April 25, 2011
Last Updated
September 14, 2015
Sponsor
Kanto CML Study Group
Collaborators
Epidemiological and Clinical Research Information Network
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1. Study Identification

Unique Protocol Identification Number
NCT01342679
Brief Title
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
Acronym
CMR-CML
Official Title
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kanto CML Study Group
Collaborators
Epidemiological and Clinical Research Information Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
chronic myeloid leukemia, dasatinib, complete molecular response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dasatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dasatinib
Other Intervention Name(s)
BMS-354825
Intervention Description
100mg QD
Primary Outcome Measure Information:
Title
Rate of complete molecular response (CMR) after treatment with dasatinib
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Dasatinib of dose intensity
Time Frame
at 12 months
Title
Expansions rate of large granular lymphocyte
Time Frame
at 12 months
Title
Progression free survival
Time Frame
at 12 months
Title
Number of Participants with Adverse Events
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chikashi Yoshida, MD, PhD
Organizational Affiliation
National Hospital Organization, Mito Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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