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

NCT06073769 | Recruiting FDA Drug

• 1 other identifier: CA055-007
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 2

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).

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants receiving oral azacitidine maintenance therapy

Drug: Oral azacitidine

Interventions

Oral azacitidine DRUG

Maintenance therapy according to the approved label

Participants receiving oral azacitidine maintenance therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults in Korea with acute myeloid leukemia receiving maintenance therapy with oral azacitidine 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).

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Seoul, 06234, South Korea

TERMINATED

Novotech Laboratory Korea Co., Ltd.

Seoul, 06234, South Korea

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)