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

NCT06565975 | Completed FDA Drug

• 1 other identifier: CA055-1047
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute myeloid leukemia (AML)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (23)

• Participant baseline demographics

  Baseline

• Type of acute myeloid (AML)

  Baseline

• Participant cytogenetic abnomalities

  Baseline

• Participant gene mutation status

  Baseline

• Participant cytogenetic and mutational risk category

  Baseline

Study Arms (1)

Participants that received maintenance treatment of oral azacitidine

Drug: Oral azacitidine

Interventions

Oral azacitidine DRUG

As per product label, prescribed by treating physician

Participants that received maintenance treatment of oral azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Kappa Sante

Paris, 75002, France

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 22, 2024
• Study Start: May 23, 2023
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)