Acute Myeloid Leukemia (AML)
Conditions
Keywords
Acute myeloid leukemia (AML)
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.
Interventions
DRUGOral azacitidine
As per product label, prescribed by treating physician
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant relapse rate | 6 and 12 months |
| Time to treatment discontinuation (TTD) | Up to 41 months |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Participant treatment history | 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 | Up to 41 months | Response types include: complete remission (CR), incomplete blood count recovery (Cri) or CR with partial hematology recovery (CRh) |
| 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 | — |
| First versus subsequent remission at the time of initiation of treatment with oral azacitidine | Baseline | — |
| Participant adverse events (AEs) | Up to 41 months | — |
| Participant baseline demographics | 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 cytogenetic and mutational risk category | Baseline | — |
Countries
France
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed