Korean Post-marketing Surveillance for Sprycel®
Conditions
Leukemia, Myelomonocytic, Chronic - Leukemia-Lymphoma
Conditions: official terms
Leukemia - Leukemia, Myelomonocytic, Chronic
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
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® so that the regulatory authority can manage the marketing approval properly.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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
Locations
Local Institution
Ansan-si, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 005
Local Institution
Anyang, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 007
Local Institution
Bucheon, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 035
Local Institution
Goyang-si, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 011
Local Institution
Goyang-si, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 010
Local Institution
Seongnam-si, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 008
Local Institution
Seongnam-si, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 003
Local Institution
Suwon, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 004
Local Institution
Suwon, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 006
Local Institution
Hwasun-gun, Jeonnam, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 020
Local Institution
Chungju, North Chungcheong, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 017
Local Institution
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 027
Local Institution
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 024
Local Institution
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 023
Local Institution
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 026
Local Institution
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 025
Local Institution
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 032
Local Institution
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 034
Local Institution
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 033
Local Institution
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 036
Local Institution
Daejeon, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 016
Local Institution
Daejeon, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 014
Local Institution
Daejeon, Korea, Republic of
Status: Recruiting
Contact: , Site 015
Local Institution
Incheon, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 022
Local Institution
Seoul, Korea, Republic of
Status: Recruiting
Contact: , Site 018
Local Institution
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 029
Local Institution
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 021
Local Institution
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 013
Local Institution
Seoul, Korea, Republic of
Status: Recruiting
Contact: , Site 001
Local Institution
Seoul, Korea, Republic of
Status: Recruiting
Contact: , Site 002
Local Institution
Seoul, Korea, Republic of
Status: Recruiting
Contact: , Site 019
Local Institution
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 009
Local Institution
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 031
Local Institution
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 030
Local Institution
Seoul, Korea, Republic of
Status: Recruiting
Contact: , Site 012
Local Institution
Ulsan, Korea, Republic of
Status: Not yet recruiting
Contact: , Site 028
Start Date
December 2011
Completion Date
December 2016
Sponsors
Bristol-Myers Squibb
Source
Bristol-Myers Squibb
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page