Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial

NCT ID: NCT01887561

Last Updated: 2013-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.

Detailed Description

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Conditions

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Myelogenous Leukemia, Chronic, Chronic Phase

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

Group Type NO_INTERVENTION

dasatinib

Intervention Type DRUG

Interventions

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dasatinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
* 15 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.
* female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period
* 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 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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kanto CML Study Group

OTHER

Sponsor Role lead

Responsible Party

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Naoki Takezako, M.D., Ph.D.

Kanto CML Study Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Disaster Medical Center

Tachikawa, Tokyo, Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Naoki Takesako

Role: primary

+81(0) 42-526-5511

Other Identifiers

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KCSG-04

Identifier Type: -

Identifier Source: org_study_id

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