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Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in newly diagnosed adult participants who are ineligible for intensive chemotherapy in Italy.
Venetoclax in combination with azacitidine is approved in Italy to treat Acute myeloid leukemia (AML) in newly diagnosed adults who are ineligible for intensive chemotherapy. All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 150 participants will be enrolled in the study at approximately 20-25 sites in Italy.
Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) injection according to the approved local label. The duration of the study is approximately 18 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + Azacitidine Participants | Participants treated with venetoclax in combination with azacitidine in accordance with approved local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as time from treatment initiation to death from any cause. | Up to 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed AML participants who are ineligible to intensive chemotherapy, that starting treatment with Venetoclax in combination with azacitadine treated according to the Italian label.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presidio Ospedaliero Vito Fazzi /ID# 261222 | Lecce | Apulia | 73100 | Italy | ||
| Azienda Ospedaliero Universitaria Careggi /ID# 259766 |
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| Florence |
| Firenze |
| 50134 |
| Italy |
| Ospedale San Martino /ID# 258981 | Genoa | Genova | 16132 | Italy |
| IRCCS Istituto Clinico Humanitas /ID# 259300 | Rozzano | Lombardy | 20089 | Italy |
| ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833 | Busto Arsizio | Milano | 21052 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 259455 | Milan | Milano | 20162 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 261794 | Naples | Napoli | 80131 | Italy |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258720 | Turin | Piedmont | 10126 | Italy |
| Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 260963 | Meldola | Reggio Emilia | 47014 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260683 | Rome | Roma | 00133 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 260821 | Rome | Roma | 00161 | Italy |
| AST Pesaro Urbino /ID# 261400 | Pesaro | The Marches | 61122 | Italy |
| Azienda Ospedaliero Universitaria delle Marche /ID# 261822 | Ancona | 60020 | Italy |
| ASST Papa Giovanni XXIII /ID# 258727 | Bergamo | 24127 | Italy |
| IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 259535 | Bologna | 40138 | Italy |
| AOU Policlinico G. Rodolico - San Marco /ID# 261223 | Catania | 95123 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260738 | Milan | 20122 | Italy |
| Azienda Ospedaliero-Universitaria di Modena /ID# 259189 | Modena | 41124 | Italy |
| Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 259778 | Novara | 28100 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261146 | Palermo | 90146 | Italy |
| Fondazione IRCCS Policlinico San Matteo /ID# 259624 | Pavia | 27100 | Italy |
| Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 258983 | Perugia | 06156 | Italy |
| Azienda Sanitaria Locale Pescara-Presidio Ospedaliero S.Spirito /ID# 261304 | Pescara | 65124 | Italy |
| Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 260737 | Reggio Calabria | 89125 | Italy |
| AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 259456 | Salerno | 84131 | Italy |
| Azienda Sanitaria Universitaria Giuliano Isontina /ID# 261298 | Trieste | 34128 | Italy |
| Azienda Ospedaliera Universitaria Integrata di Verona /ID# 260809 | Verona | 37134 | Italy |
| Ospedale Belcolle /ID# 259563 | Viterbo | 01100 | Italy |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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