Korean Post-marketing Surveillance for Sprycel®
N/A
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Leukemia, Myelomonocytic, Chronic, Leukemia-Lymphoma
Both
Leukemia, Myelomonocytic, Chronic, Leukemia-Lymphoma
Trial Information
Korean Post-marketing Surveillance for Sprycel®
Inclusion Criteria:
- Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
(CML) in chronic phase
- Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with
resistance or intolerance to prior therapy including Imatinib
- Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)
with resistance or intolerance to prior therapy
Exclusion Criteria:
- According to Warning/Caution in local label
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Adverse events occurrence
Outcome Time Frame:
30 days after last dose of study drug
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Korea: Food and Drug Administration
Study ID:
CA180-370
NCT ID:
NCT01464047
Start Date:
December 2011
Completion Date:
August 2016
Related Keywords:
- Leukemia, Myelomonocytic, Chronic
- Leukemia-Lymphoma
- Leukemia
- Leukemia, Myelomonocytic, Chronic
- Lymphoma
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