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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants that received maintenance treatment of oral azacitidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral azacitidine | Drug | As per product label, prescribed by treating physician |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Participants who do not object to the data collection
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kappa Sante | Paris | 75002 | France |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| 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 |
| 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 | 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |