Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France

• Oral azacitidine (Drug): As per product label, prescribed by treating physician

Primary outcomes

• Participant real-world relapse-free survival (rw-RFS) [Up to date of documented relapse or death assessed up to 41 months]
• Participant overall survival (OS) [Up to date of documented death assessed up to 41 months]
• Participant relapsed-free survival (RFS) [From date of achieved complete remission up to 41 months]
• Participant overall survival (OS) from the time of complete remission achievement [From date of achieved complete remission up to 41 months]
• Participant relapse rate [6 and 12 months]
• Time to treatment discontinuation (TTD) [Up to 41 months]

Secondary outcomes

• Participant baseline demographics [Baseline]
• Type of acute myeloid (AML) [Baseline]: AML types include: de novo, or secondary AML (therapy-related AML, or secondary to a myeloid disorder)
• Participant cytogenetic abnomalities [Baseline]
• Participant gene mutation status [Baseline]
• Participant cytogenetic and mutational risk category [Baseline]
• Participant acute myeloid (AML) classification as per World Health Organization [Baseline]
• Participant bone marrow blast percentage [Baseline]
• Participant hemoglobin levels [Baseline]
• Participant blood test results [Baseline]
• Participant Eastern Cooperative Oncology Group or Karnofsky score [Baseline]
• Participant diagnosis history of other hematological disorders [Baseline]
• Participant treatment history [Baseline]
• Minimal residual disease status (MRD) [Baseline]
• Reason for stem cell transplant ineligibility post initial frontline treatment [Baseline]
• Participant response type at the initiation of maintenance therapy [Up to 41 months]: Response types include: complete remission (CR), incomplete blood count recovery (Cri) or CR with partial hematology recovery (CRh)
• First versus subsequent remission at the time of initiation of treatment with oral azacitidine [Baseline]
• Criteria to define complete remission (CR), incomplete blood count recovery (Cri), and CR with partial hematology recovery (CRh) at time of initiation of oral azacitidine [Baseline]
• Oral azacitidine treatment regimen [Up to 41 months]
• Concomitant support treatment received with oral azacitidine [Up to 41 months]
• Duration of oral azacitidine treatment [Up to 41 months]
• Reason for oral azacitidine treatment discontinuation [Up to 41 months]
• Treatments/procedures following oral azacitidine cessation [Up to 41 months]
• Participant adverse events (AEs) [Up to 41 months]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Participants who initiated oral azacitidine maintenance therapy during early access program (EAP) in France (January 29, 2021 to July 13, 2022) or during the 6 months post-EAP (from July 14, 2022, to January 2014, 2023) inside the marketing authorization label "adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT)."
* 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:

* Participants who initiated maintenance with oral azacitidine after January 14, 2023
* Participant who initiated maintenance with oral azacitidine before January 14, 2023, outside of the marketing authorization label

• Bristol-Myers Squibb, Study director, Bristol-Myers Squibb