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

Recruiting now

Conditions studied: Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT06073769

Run by

Bristol-Myers Squibb

People needed

154

Starts

2023-11-15

Expected to finish

2027-07-30

Last updated by the study team

2024-11-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (enrolling)
• Local Institution - 0001 — Seoul, South Korea

Full record on ClinicalTrials.gov

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