Korean Post-marketing Surveillance for Sprycel®

Completed

• Conditions: Leukemia, Myelomonocytic, Chronic; Leukemia-Lymphoma

• Registration Number: NCT01464047
• Lead Sponsor: Bristol-Myers Squibb

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 available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-03
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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

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Exclusion Criteria

• According to Warning/Caution in local label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events occurrence	30 days after last dose of study drug

Secondary Outcome Measures

Name	Time	Method
Improvement in cytogenetic response	12 weeks after registration	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
Improvement in hematologic response	4 weeks after registration	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
Overall efficacy assessment by investigator's discretion	4 weeks after registration	Based on demographic factors, treatment factors like medical history and concomitant medication

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of