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
VERO
Venetoclax Real-World Observational Study on Effectiveness and Treatment Management in Patients With Newly Diagnosed AML Who Are Ineligible for Intensive Chemotherapy in Italy
1 other identifier
observational
150
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2024
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
April 22, 2025
April 1, 2025
2.7 years
September 22, 2023
April 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as time from treatment initiation to death from any cause.
Up to 18 Months
Study Arms (1)
Venetoclax + Azacitidine Participants
Participants treated with venetoclax in combination with azacitidine in accordance with approved local label.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (28)
Presidio Ospedaliero Vito Fazzi /ID# 261222
Lecce, Apulia, 73100, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 259766
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2023
First Posted
September 28, 2023
Study Start
March 4, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
April 22, 2025
Record last verified: 2025-04