Korean Post-marketing Surveillance for Sprycel®

This study is currently recruiting participants.
Verified March 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01464047
First received: October 10, 2011
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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.


Condition
Leukemia, Myelomonocytic, Chronic
Leukemia-Lymphoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Post-marketing Surveillance for Sprycel®

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse events occurrence [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in hematologic response [ Time Frame: 4 weeks after registration ] [ Designated as safety issue: No ]
    The number and percentage of subjects who satisfy each criterion of hematologic responses (Complete/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value

  • Improvement in cytogenetic response [ Time Frame: 12 weeks after registration ] [ Designated as safety issue: No ]
    The number and percentage of subjects who satisfy each criterion of cytogenetic responses (Complete/Partial/Minor/Minimal/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value

  • Overall efficacy assessment by investigator's discretion [ Time Frame: 4 weeks after registration ] [ Designated as safety issue: No ]
    Based on demographic factors, treatment factors like medical history and concomitant medication


Estimated Enrollment: 600
Study Start Date: December 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with CML or Ph+ ALL

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who were never treated with Sprycel®

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464047

Contacts
Contact: For site information please email : Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site# . Only trial sites that are recruiting have contact information

Locations
Korea, Republic of
Local Institution Not yet recruiting
Ansan-si, Gyeonggi-do, Korea, Republic of, 425-707
Contact: , Site 005         
Local Institution Not yet recruiting
Anyang, Gyeonggi-do, Korea, Republic of, 431-070
Contact: , Site 007         
Local Institution Not yet recruiting
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Contact: , Site 035         
Local Institution Not yet recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 412-270
Contact: , Site 010         
Local Institution Not yet recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-719
Contact: , Site 011         
Local Institution Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: , Site 008         
Local Institution Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Contact: , Site 003         
Local Institution Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 443-721
Contact: , Site 006         
Local Institution Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Contact: , Site 004         
Local Institution Not yet recruiting
Hwasun-gun, Jeonnam, Korea, Republic of, 519-809
Contact: , Site 020         
Local Institution Not yet recruiting
Chungju, North Chungcheong, Korea, Republic of, 361-711
Contact: , Site 017         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 100-032
Contact: , Site 027         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 602-739
Contact: , Site 023         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 603-714
Contact: , Site 026         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 614-735
Contact: , Site 025         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 602-702
Contact: , Site 024         
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 700-712
Contact: , Site 036         
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 705-717
Contact: , Site 033         
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 705-718
Contact: , Site 032         
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 700-721
Contact: , Site 034         
Local Institution Recruiting
Daejeon, Korea, Republic of, 302-799
Contact: , Site 015         
Local Institution Not yet recruiting
Daejeon, Korea, Republic of, 302-718
Contact: , Site 014         
Local Institution Not yet recruiting
Daejeon, Korea, Republic of, 301-721
Contact: , Site 016         
Local Institution Not yet recruiting
Incheon, Korea, Republic of, 405-760
Contact: , Site 022         
Local Institution Recruiting
Seoul, Korea, Republic of, 138-736
Contact: , Site 012         
Local Institution Recruiting
Seoul, Korea, Republic of, 137-701
Contact: , Site 002         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 140-743
Contact: , Site 009         
Local Institution Recruiting
Seoul, Korea, Republic of, 137-701
Contact: , Site 001         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 158-710
Contact: , Site 013         
Local Institution Recruiting
Seoul, Korea, Republic of, 136-705
Contact: , Site 018         
Local Institution Recruiting
Seoul, Korea, Republic of, 110-744
Contact: , Site 019         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: , Site 021         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: , Site 029         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 156-755
Contact: , Site 030         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 152-703
Contact: , Site 031         
Local Institution Not yet recruiting
Ulsan, Korea, Republic of, 682-714
Contact: , Site 028         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01464047     History of Changes
Other Study ID Numbers: CA180-370
Study First Received: October 10, 2011
Last Updated: March 5, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Chronic
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014