The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of oral azacitidine prescribed as maintenance treatment after frontline treatment or second remission for acute myeloid leukemia in France.
Study Type
OBSERVATIONAL
Enrollment
112
As per product label, prescribed by treating physician
Kappa Sante
Paris, France
Participant real-world relapse-free survival (rw-RFS)
Time frame: Up to date of documented relapse or death assessed up to 41 months
Participant overall survival (OS)
Time frame: Up to date of documented death assessed up to 41 months
Participant relapsed-free survival (RFS)
Time frame: From date of achieved complete remission up to 41 months
Participant overall survival (OS) from the time of complete remission achievement
Time frame: From date of achieved complete remission up to 41 months
Participant relapse rate
Time frame: 6 and 12 months
Time to treatment discontinuation (TTD)
Time frame: Up to 41 months
Participant baseline demographics
Time frame: Baseline
Type of acute myeloid (AML)
AML types include: de novo, or secondary AML (therapy-related AML, or secondary to a myeloid disorder)
Time frame: Baseline
Participant cytogenetic abnomalities
Time frame: Baseline
Participant gene mutation status
Time frame: Baseline
Participant cytogenetic and mutational risk category
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Time frame: Baseline
Participant acute myeloid (AML) classification as per World Health Organization
Time frame: Baseline
Participant bone marrow blast percentage
Time frame: Baseline
Participant hemoglobin levels
Time frame: Baseline
Participant blood test results
Time frame: Baseline
Participant Eastern Cooperative Oncology Group or Karnofsky score
Time frame: Baseline
Participant diagnosis history of other hematological disorders
Time frame: Baseline
Participant treatment history
Time frame: Baseline
Minimal residual disease status (MRD)
Time frame: Baseline
Reason for stem cell transplant ineligibility post initial frontline treatment
Time frame: Baseline
Participant response type at the initiation of maintenance therapy
Response types include: complete remission (CR), incomplete blood count recovery (Cri) or CR with partial hematology recovery (CRh)
Time frame: Up to 41 months
First versus subsequent remission at the time of initiation of treatment with oral azacitidine
Time frame: 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
Time frame: Baseline
Oral azacitidine treatment regimen
Time frame: Up to 41 months
Concomitant support treatment received with oral azacitidine
Time frame: Up to 41 months
Duration of oral azacitidine treatment
Time frame: Up to 41 months
Reason for oral azacitidine treatment discontinuation
Time frame: Up to 41 months
Treatments/procedures following oral azacitidine cessation
Time frame: Up to 41 months
Participant adverse events (AEs)
Time frame: Up to 41 months