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Trial Title:
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
NCT ID:
NCT06073769
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Oral azacitidine
Description:
Maintenance therapy according to the approved label
Arm group label:
Participants receiving oral azacitidine maintenance therapy
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).
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0001
Address:
City:
Seoul
Zip:
06234
Country:
Korea, Republic of
Status:
Terminated
Facility:
Name:
Novotech Laboratory Korea Co., Ltd.
Address:
City:
Seoul
Zip:
06234
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
South Korea Generic Country, Site 0002
Phone:
0000000000
Start date:
November 15, 2023
Completion date:
July 30, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073769
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.fda.gov/safety
