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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06073769
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Oral azacitidine

Study Design

• Study Type: Observational
• Anticipated Enrollment: 154 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
• Anticipated Study Start Date: Sep 30, 2023
• Anticipated Primary Completion Date: Jan 31, 2028
• Anticipated Study Completion Date: Sep 30, 2029

Arms and Interventions

Arm	Intervention/Treatment
Participants receiving oral azacitidine maintenance therapy	Drug: Oral azacitidine; Maintenance therapy according to the approved label

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events (AES) [Up to 12 months]

   The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bristol-Myers Squibb YH	Seoul		Korea, Republic of	06178

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT06073769
• Other Study ID Numbers: CA055-007
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Azacitidine

Study Results

No Results Posted as of Oct 10, 2023