A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
NCT ID: NCT06073769
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
154 participants
OBSERVATIONAL
2023-11-15
2027-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants receiving oral azacitidine maintenance therapy
Oral azacitidine
Maintenance therapy according to the approved label
Interventions
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Oral azacitidine
Maintenance therapy according to the approved label
Eligibility Criteria
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Inclusion Criteria
* Participants who receive oral azacitidine according to the approved label
* For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered
* Participants who sign the informed consent form
Exclusion Criteria
* Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety
19 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Seoul, , South Korea
Novotech Laboratory Korea Co., Ltd.
Seoul, , South Korea
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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South Korea Generic Country, Site 0002
Role: primary
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CA055-007
Identifier Type: -
Identifier Source: org_study_id
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