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NCT06073769 Clinical Trial

A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06073769
Other study ID # CA055-007
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2023
Est. completion date May 30, 2029

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).

Recruitment information / eligibility
Status Recruiting
Enrollment 154
Est. completion date May 30, 2029
Est. primary completion date August 31, 2027
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Adult participants 19 years of age or older - 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 who are prescribed oral azacitidine for therapeutic indications not approved in Korea - Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral azacitidine
Maintenance therapy according to the approved label

Locations
Country Name City State
Korea, Republic of PPC Korea Co.,Ltd 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 Number of participants with adverse events (AES) The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine Up to 12 months
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