Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France
- Registration Number
- NCT06565975
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
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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)."
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Participants with histologically confirmed diagnosis of de novo AML, or therapy-related AML, or secondary AML
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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
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Participant is at least 18 years of age at the time of initial diagnosis of AML
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Participants alive or deceased at the time of data collection
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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
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Participants who do not object to the data collection
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants that received maintenance treatment of oral azacitidine Oral azacitidine -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Minimal residual disease status (MRD) Baseline Participant acute myeloid (AML) classification as per World Health Organization Baseline Participant bone marrow blast percentage Baseline Participant blood test results Baseline Participant treatment history Baseline Participant response type at the initiation of maintenance therapy Up to 41 months Response types include: complete remission (CR), incomplete blood count recovery (Cri) or CR with partial hematology recovery (CRh)
Oral azacitidine treatment regimen Up to 41 months Participant baseline demographics Baseline Participant cytogenetic and mutational risk category Baseline Participant hemoglobin levels 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 Type of acute myeloid (AML) Baseline AML types include: de novo, or secondary AML (therapy-related AML, or secondary to a myeloid disorder)
Participant cytogenetic abnomalities Baseline Participant gene mutation status Baseline Participant Eastern Cooperative Oncology Group or Karnofsky score Baseline Participant diagnosis history of other hematological disorders Baseline Reason for stem cell transplant ineligibility post initial frontline treatment Baseline First versus subsequent remission at the time of initiation of treatment with oral azacitidine Baseline 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
Trial Locations
- Locations (1)
Kappa Sante
đŸ‡«đŸ‡·Paris, France