Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
NCT ID: NCT06565975
Last Updated: 2024-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
112 participants
OBSERVATIONAL
2023-05-23
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants that received maintenance treatment of oral azacitidine
Oral azacitidine
As per product label, prescribed by treating physician
Interventions
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Oral azacitidine
As per product label, prescribed by treating physician
Eligibility Criteria
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Inclusion Criteria
* Participants with histologically confirmed diagnosis of de novo AML, or therapy-related AML, or secondary AML
* Participants who received frontline treatment after diagnosis of AML and achieved complete remission (CR), CR with incomplete blood count recovery (Cri), or CR with partial hematology recovery (CRh) after one or subsequent lines of therapy in case of relapse
* Participant is at least 18 years of age at the time of initial diagnosis of AML
* Participants alive or deceased at the time of data collection
* Physician has access to the complete medical record for the patient, including any transferred records from other facilities (if applicable); patient's medical record must at least include the following:
* Date of diagnosis of AML
* Frontline therapy(ies) received, and treatment start dates
* Date(s) of first documented evidence of response
* Oral azacitidine start and (if applicable) stop date
* Documentation (yes/no) of relapse on oral azacitidine, where applicable
* Participants who do not object to the data collection
Exclusion Criteria
* Participant who initiated maintenance with oral azacitidine before January 14, 2023, outside of the marketing authorization label
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Kappa Sante
Paris, , France
Countries
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Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA055-1047
Identifier Type: -
Identifier Source: org_study_id
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