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

Acute Myeloid Leukemia Clinical Trial

— VERO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058741
• Other study ID #: P23-498
• Status: Recruiting
• Start date: March 4, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: Annalisa Iezzi
• Phone: +39 06 928923024
• Email: annalisa.iezzi[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of primary or secondary acute myeloid leukemia (AML), deemed ineligible for intensive induction chemotherapy because of age, performance status, comorbidities or any other clinical reason as defined by the treating physician.
• Investigator decision on patient treatment with venetoclax + azacitidine must have been reached prior to and independently of recruitment in the study.
• Treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.

Exclusion Criteria:

• Participants affected by Acute Promyelocytic Leukemia.
• Prior treatment for AML, excluding hydroxyurea.
• Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another post-marketing observational study or Registry is acceptable

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 259535	Bologna
Italy	ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833	Busto Arsizio	Milano
Italy	Presidio Ospedaliero Gaspare Rodolico /ID# 261223	Catania
Italy	Presidio Ospedaliero Vito Fazzi /ID# 261222	Lecce	Puglia
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 259455	Milan	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 259189	Modena
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	Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 260737	Reggio Calabria
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 260683	Rome	Roma
Italy	Sapienza University /ID# 260821	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 259300	Rozzano	Milano
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 261822	Torette	Ancona
Italy	Azienda Sanitaria Universitaria Giuliano Isontina /ID# 261298	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is defined as time from treatment initiation to death from any cause.	Up to 18 Months

External Links

•   Related Info