Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
N/A
20 Months
N/A
20 Months
N/A
Open (Enrolling)
Both
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelogenous Leukemia, Chronic, Chronic Phase
Both
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelogenous Leukemia, Chronic, Chronic Phase
Trial Information
Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Inclusion Criteria:
- Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
- 20 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
- The case of Pleural effusion clearly
- Patients with complications or a history of severe or uncontrolled cardiovascular
failure following
- have a Myocardial infarction whithin 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:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Rate of complete molecular response (CMR) after treatment with dasatinib
Outcome Description:
The rate(%) of patients who achieve complete molecular response (CMR) by 18 months after the dasatinib therapy will be measured to evaluate the efficiency of dasatinib.
Outcome Time Frame:
by 18 months
Safety Issue:
No
Authority:
Japan: Institutional Review Board
Study ID:
KCSG-03
NCT ID:
NCT01464411
Start Date:
July 2011
Completion Date:
Related Keywords:
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myelogenous Leukemia, Chronic, Chronic Phase
- chronic myelogenous leukemia
- chronic phase
- Phase II
- dasatinib
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Chronic Disease
Name | Location |
|---|
