Actively Recruiting
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Led by Bristol-Myers Squibb · Updated on 2024-11-06
154
Participants Needed
2
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 19 years of age or older
- Receiving oral azacitidine according to the approved label
- All participants treated with oral azacitidine within the first 2 years after marketing authorization will be registered
- Signed informed consent form
You will not qualify if you...
- Prescribed oral azacitidine for unapproved indications in Korea
- Oral azacitidine contraindicated as per Korean prescribing information approved by the Ministry of Food and Drug Safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Local Institution - 0001
Seoul, South Korea, 06234
Terminated
2
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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