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

RELION Study: Characteristics and Outcomes of the Patient Population With Acute Myeloid Leukemia in Remission, Treated With Oral Azacitidine Maintenance in France

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 Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia (AML)
• Intervention / Treatment: Drug: Oral azacitidine

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• France
  • Paris, France, 75002
    • Kappa Santé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with histologically confirmed de novo acute myeloid leukemia, therapy-related acute myeloid leukemia, or secondary acute myeloid leukemia who received maintenance therapy with oral azacitidine while in remission after front-line treatment or in second remission

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants that received maintenance treatment of oral azacitidine	Drug: Oral azacitidine; As per product label, prescribed by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Participant treatment history		Baseline
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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Acute myeloid leukemia (AML)
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Aza Compounds; Nucleosides; Ribonucleosides; Azacitidine
• Other Study ID Numbers: CA055-1047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No