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

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Oral azacitidine

Study type: Observational

Funder types: Industry

Identifiers

NCT06565975

CA055-1047

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

112 participants in 1 patient group

Participants that received maintenance treatment of oral azacitidine

Treatment:

Drug: Oral azacitidine