Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT06058741
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 261822, Torette, Ancona, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 259455, Milan, Milano, Italy
Istituto Clinico Humanitas /ID# 259300, Rozzano, Milano, Italy
Presidio Ospedaliero Vito Fazzi /ID# 261222, Lecce, Puglia, Italy
Fondazione PTV Policlinico Tor Vergata /ID# 260683, Rome, Roma, Italy
Sapienza University /ID# 260821, Rome, Roma, Italy
Presidio Ospedaliero Gaspare Rodolico /ID# 261223, Catania, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 259778, Novara, , Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 261146, Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo /ID# 259624, Pavia, , Italy
Azienda Sanitaria Locale Pescara-Presidio Ospedaliero S.Spirito /ID# 261304, Pescara, , Italy
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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