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


Phase 2
20 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at 12 months

Safety Issue:

No

Principal Investigator

Chikashi Yoshida, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Hospital Organization, Mito Medical Center

Authority:

Japan: Institutional Review Board

Study ID:

KCSG-02

NCT ID:

NCT01342679

Start Date:

April 2011

Completion Date:

April 2013

Related Keywords:

  • Chronic Myeloid Leukemia
  • chronic myeloid leukemia
  • dasatinib
  • complete molecular response
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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