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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Oral azacitidine

Study type: Observational

Funder types: Industry

Identifiers

NCT06073769

CA055-007

Details and patient eligibility

About

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).

Enrollment: 154 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

154 participants in 1 patient group

Participants receiving oral azacitidine maintenance therapy

Treatment:

Drug: Oral azacitidine