Status:
COMPLETED
Korean Post-marketing Surveillance for Sprycel®
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia, Myelomonocytic, Chronic
Leukemia-Lymphoma
Eligibility:
All Genders
Brief Summary
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® ...
Eligibility Criteria
Inclusion
- 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
- According to Warning/Caution in local label
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT01464047
Start Date
October 1 2011
End Date
August 1 2015
Last Update
April 27 2016
Active Locations (1)
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1
Local Institution
Seoul, South Korea, 110-756