JPRN-UMIN000008583
Completed
Phase 2
Clinical research of safety and efficacy after a stop of dasatinib administration in patients with chronic myeloid leukemia -chronic phase (CML-CP) achieving a complete molecular response (CMR) on a treatment of tyrosine kinase inhibitors (TKIs). - Stop dasatinib study (STDAST)
CML stem cell study group0 sites141 target enrollmentAugust 1, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic myeloid leukemia -chronic phase (CML-CP)
- Sponsor
- CML stem cell study group
- Enrollment
- 141
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Patients who attend other clinical trial. 2\) BCR\-ABL point mutation (T315I, F317L, V299L) 3\) QTc interval prolongation (\>450msec) 4\) Patient who has clear pleural effusion 5\) Patients who have the following cardiovascular dysfunction 1\. Impossible to measure QT interval in ECG 2\. Complete left bundle branch block 3\. Internal pacemaker 4\. Congenital long QT syndrome or family history 5\. Tachycardia 6\. Bradycardia (\<50bpm) 7\. Myocardial infarction within 6 months 8\. Angina pectoris within 3 months 9\. Congestive heart failure within 3 months 10\. Patient who have the complications of cardiovascular disorder 6\) Active double cancer 7\) Pregnant or breastfeeding woman 8\) Patient who have complications with serious or poor control 9\) Mental disorder 10\) Cognitive dysfunction 11\) Patient who judges the investigator to have difficulty in participation in study.
Outcomes
Primary Outcomes
Not specified
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