Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group
ClinicalTrials.gov Identifier:
NCT01342679
First received: April 25, 2011
Last updated: September 14, 2015
Last verified: April 2011
  Purpose
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia

Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: dasatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

Resource links provided by NLM:


Further study details as provided by Kanto CML Study Group:

Primary Outcome Measures:
  • Rate of complete molecular response (CMR) after treatment with dasatinib [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dasatinib of dose intensity [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Expansions rate of large granular lymphocyte [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: April 2011
Study Completion Date: September 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dasatinib Drug: dasatinib
100mg QD
Other Name: BMS-354825

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342679

Locations
Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
Sponsors and Collaborators
Kanto CML Study Group
Epidemiological and Clinical Research Information Network
Investigators
Principal Investigator: Chikashi Yoshida, MD, PhD National Hospital Organization, Mito Medical Center
  More Information

Responsible Party: Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
ClinicalTrials.gov Identifier: NCT01342679     History of Changes
Other Study ID Numbers: KCSG-02 
Study First Received: April 25, 2011
Last Updated: September 14, 2015
Health Authority: Japan: Institutional Review Board

Keywords provided by Kanto CML Study Group:
chronic myeloid leukemia
dasatinib
complete molecular response

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016