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Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) patients diagnosed with AML in real life setting.
The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers (Saint-Etienne, Clermont-Ferrand, Lyon (Hopital Lyon Sud, Centre Léon Bérard), Vichy, Annecy, Chambery, Valence, Bourgoin-Jallieu, Grenoble, Roanne) in Auvergne Rhône Alpes (AURA) region, between January 2019 and December 2023. Composite complete remission was defined as in VIALE-A trial. Measurable residual disease (MRD) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for NPM1 by RT-qPCR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacytidine and venetoclax treated patients | Adult patients with acute myeloid leukemia treated by AZACYTIDINE and VENETOCLAX in frontline and relapse/refractory settings |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence. | up to 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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Every adult patients ( >18 years old) with a diagnostic of AML treated by the association of AZACYTIDINE and VENETOCLAX between January 2019 and December 2023.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord | Bourgoin | 38300 | France | |||
| METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset, |
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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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| Chambéry |
| 73000 |
| France |
| CHU Clermont-Ferrand Site Estaing | Clermont-Ferrand | 63100 | France |
| Centre Hospitalier Annecy Genevois | Épagny | 74370 | France |
| CHU Grenoble Alpes | La Tronche | France |
| Centre Léon Bérard | Lyon | 69003 | France |
| Hospices Civils de Lyon | Lyon | 69229 | France |
| Centre Hospitalier de Roanne | Roanne | 42300 | France |
| CHU de Saint-Étienne Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Centre Hospitalier de Valence | Valence | 26000 | France |
| Ch de Valence | Valence | France |
| Hopital Vichy | Vichy | 03200 | France |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |