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Completed

NCT Number: NCT01342679

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

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

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

100mg QD

Other names: BMS-354825

Primary outcomes

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

    Time frame: at 12 months

Secondary outcomes

  1. Dasatinib of dose intensity

    Time frame: at 12 months

  2. Expansions rate of large granular lymphocyte

    Time frame: at 12 months

  3. Progression free survival

    Time frame: at 12 months

  4. Number of Participants with Adverse Events

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

Kanto CML Study Group

Other

Collaborators

  • Epidemiological and Clinical Research Information Network

Registry information

Acronym: CMR-CML

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 27, 2011
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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