Korean Post-marketing Surveillance for Sprycel®

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01464047

Enrollment

670

Registered

2011-11-03

Start date

2011-10-31

Completion date

2015-08-31

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia-Lymphoma, Leukemia, Myelomonocytic, Chronic

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events occurrence	30 days after last dose of study drug

Secondary

Measure	Time frame	Description
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
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
Overall efficacy assessment by investigator's discretion	4 weeks after registration	Based on demographic factors, treatment factors like medical history and concomitant medication

Countries

South Korea

Outcome results