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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Local Institution - 0001
TERMINATED
Seoul
Novotech Laboratory Korea Co., Ltd.
RECRUITING
Seoul
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 154
Treatments
Participants receiving oral azacitidine maintenance therapy
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov