Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Asses Effectiveness and Treatment Management of Oral Venetoclax Tablets + Subcutaneously Injected Azacitidine in Adult Participants Ineligible for Intensive Chemotherapy With de Novo Acute Myeloid Leukemia (AML) in Italy
Sponsor: AbbVie
Summary
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.
Official title: Venetoclax Real-World Observational Study on Effectiveness and Treatment Management in Patients With Newly Diagnosed AML Who Are Ineligible for Intensive Chemotherapy in Italy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2024-03-04
Completion Date
2026-11
Last Updated
2025-04-22
Healthy Volunteers
No
Conditions
Locations (28)
Presidio Ospedaliero Vito Fazzi /ID# 261222
Lecce, Apulia, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 259766
Florence, Firenze, Italy
Ospedale San Martino /ID# 258981
Genoa, Genova, Italy
IRCCS Istituto Clinico Humanitas /ID# 259300
Rozzano, Lombardy, Italy
ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833
Busto Arsizio, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 259455
Milan, Milano, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 261794
Naples, Napoli, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258720
Turin, Piedmont, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 260963
Meldola, Reggio Emilia, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260683
Rome, Roma, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 260821
Rome, Roma, Italy
AST Pesaro Urbino /ID# 261400
Pesaro, The Marches, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 261822
Ancona, Italy
ASST Papa Giovanni XXIII /ID# 258727
Bergamo, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 259535
Bologna, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 261223
Catania, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260738
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 259189
Modena, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 259778
Novara, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261146
Palermo, Italy
Fondazione IRCCS Policlinico San Matteo /ID# 259624
Pavia, Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 258983
Perugia, Italy
Azienda Sanitaria Locale Pescara-Presidio Ospedaliero S.Spirito /ID# 261304
Pescara, Italy
Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 260737
Reggio Calabria, Italy
AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 259456
Salerno, Italy
Azienda Sanitaria Universitaria Giuliano Isontina /ID# 261298
Trieste, Italy
Azienda Ospedaliera Universitaria Integrata di Verona /ID# 260809
Verona, Italy
Ospedale Belcolle /ID# 259563
Viterbo, Italy