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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 10, 2011

Last Updated Date

March 5, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01464047 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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: 4 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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Korean Post-marketing Surveillance for Sprycel®

Official Title ^ICMJE

Korean Post-marketing Surveillance for Sprycel®

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® so that the regulatory authority can manage the marketing approval properly.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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®

Condition ^ICMJE

Leukemia, Myelomonocytic, Chronic
Leukemia-Lymphoma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients with CML or Ph+ ALL

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

August 2016

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01464047

Other Study ID Numbers ^ICMJE

CA180-370

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top