A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Recruiting
Observational Study
Acute Myeloid Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Study type
Observational
Participants needed
154 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
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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 …
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).
Trial Locations
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Eligibility 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
* Partici…
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
BMS Study Connect Contact Center www.BMSStudyConnect.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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