Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
NCT Number: NCT06565975
Acronym: RELION
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myeloid Leukemia (AML)
Interventions: DRUG: Oral azacitidine
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 112
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-23
Completion Date: 2024-10-31
Locations: Kappa Sante, Paris, 75002, France

Summary:
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.

Primary Outcome Measures: 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 Outcome Measures: Participant baseline demographics, Baseline|Type of acute myeloid (AML), AML types include: de novo, or secondary AML (therapy-related AML, or secondary to a myeloid disorder), Baseline|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, Response types include: complete remission (CR), incomplete blood count recovery (Cri) or CR with partial hematology recovery (CRh), Up to 41 months|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