Korean Post-marketing Surveillance for Sprycel®

Leukemia, Myelomonocytic, Chronic Clinical Trial

Official title:

Korean Post-marketing Surveillance for Sprycel®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464047
• Other study ID #: CA180-370
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: April 25, 2016
• Start date: October 2011
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelomonocytic, Chronic
• Leukemia-Lymphoma

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events occurrence		30 days after last dose of study drug	Yes
Secondary	Improvement in hematologic response	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	4 weeks after registration	No
Secondary	Improvement in cytogenetic response	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	12 weeks after registration	No
Secondary	Overall efficacy assessment by investigator's discretion	Based on demographic factors, treatment factors like medical history and concomitant medication	4 weeks after registration	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form