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PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS


Phase 2
15 Years
N/A
Open (Enrolling)
Both
Myelogenous Leukemia, Chronic, Chronic Phase

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Trial Information

PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR

Outcome Time Frame:

by 12 months

Safety Issue:

No

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

KCSG-04

NCT ID:

NCT01887561

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Myelogenous Leukemia, Chronic, Chronic Phase
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Chronic Disease

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