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Completed

NCT Number: NCT06565975

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

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kappa Sante

Paris, 75002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Azacitidine

Drug

As per product label, prescribed by treating physician

Primary outcomes

  1. Participant real-world relapse-free survival (rw-RFS)

    Time frame: Up to date of documented relapse or death assessed up to 41 months

  2. Participant overall survival (OS)

    Time frame: Up to date of documented death assessed up to 41 months

  3. Participant relapsed-free survival (RFS)

    Time frame: From date of achieved complete remission up to 41 months

  4. Participant overall survival (OS) from the time of complete remission achievement

    Time frame: From date of achieved complete remission up to 41 months

  5. Participant relapse rate

    Time frame: 6 and 12 months

  6. Time to treatment discontinuation (TTD)

    Time frame: Up to 41 months

Secondary outcomes

  1. Participant baseline demographics

    Time frame: Baseline

  2. Type of acute myeloid (AML)

    Time frame: Baseline

    AML types include: de novo, or secondary AML (therapy-related AML, or secondary to a myeloid disorder)

  3. Participant cytogenetic abnomalities

    Time frame: Baseline

  4. Participant gene mutation status

    Time frame: Baseline

  5. Participant cytogenetic and mutational risk category

    Time frame: Baseline

  6. Participant acute myeloid (AML) classification as per World Health Organization

    Time frame: Baseline

  7. Participant bone marrow blast percentage

    Time frame: Baseline

  8. Participant hemoglobin levels

    Time frame: Baseline

  9. Participant blood test results

    Time frame: Baseline

  10. Participant Eastern Cooperative Oncology Group or Karnofsky score

    Time frame: Baseline

  11. Participant diagnosis history of other hematological disorders

    Time frame: Baseline

  12. Participant treatment history

    Time frame: Baseline

  13. Minimal residual disease status (MRD)

    Time frame: Baseline

  14. Reason for stem cell transplant ineligibility post initial frontline treatment

    Time frame: Baseline

  15. Participant response type at the initiation of maintenance therapy

    Time frame: Up to 41 months

    Response types include: complete remission (CR), incomplete blood count recovery (Cri) or CR with partial hematology recovery (CRh)

  16. First versus subsequent remission at the time of initiation of treatment with oral azacitidine

    Time frame: Baseline

  17. 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

  18. Oral azacitidine treatment regimen

    Time frame: Up to 41 months

  19. Concomitant support treatment received with oral azacitidine

    Time frame: Up to 41 months

  20. Duration of oral azacitidine treatment

    Time frame: Up to 41 months

  21. Reason for oral azacitidine treatment discontinuation

    Time frame: Up to 41 months

  22. Treatments/procedures following oral azacitidine cessation

    Time frame: Up to 41 months

  23. Participant adverse events (AEs)

    Time frame: Up to 41 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: RELION

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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