Acute Myeloid LeukemiaVERONCT06058741
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
An observational study of Acute Myeloid Leukemia, run by AbbVie at 28 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 151 participants
- Where
- 28 sitesItaly
- Study dates
- 4 Mar 2024to 21 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Italy28 sites
Azienda Ospedaliero Universitaria delle Marche /ID# 261822
Ancona, 60126
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII /ID# 258727
Bergamo, 24127
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 259535
Bologna, 40138
ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833
Busto Arsizio, Milano, 21052
AOU Policlinico G. Rodolico - San Marco /ID# 261223
Catania, 95123
Azienda Ospedaliero Universitaria Careggi /ID# 259766
Florence, Firenze, 50134
Ospedale San Martino /ID# 258981
Genova, 16132
Presidio Ospedaliero Vito Fazzi /ID# 261222
Lecce, Apulia, 73100
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 260963
Meldola, Forlì-Cesena, 47014
ASST Grande Ospedale Metropolitano Niguarda /ID# 259455
Milan, Milano, 20162
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 260738
Milan, 20122
Azienda Ospedaliero-Universitaria di Modena /ID# 259189
Modena, 41124
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 261794
Naples, Napoli, 80131
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 259778
Novara, 28100
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261146
Palermo, 90146
Fondazione IRCCS Policlinico San Matteo /ID# 259624
Pavia, 27100
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 258983
Perugia, 06156
AST Pesaro Urbino - P.O. San Salvatore - Stab. di Muraglia /ID# 261400
Pesaro, The Marches, 61122
Azienda Sanitaria Locale Pescara-Presidio Ospedaliero S.Spirito /ID# 261304
Pescara, 65124
Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 260737
Reggio Calabria, 89125
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260683
Rome, Roma, 00133
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 260821
Rome, Roma, 00161
IRCCS Istituto Clinico Humanitas /ID# 259300
Rozzano, Lombardy, 20089
AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 259456
Salerno, 84131
Azienda Sanitaria Universitaria Giuliano Isontina /ID# 261298
Trieste, 34128
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258720
Turin, Piedmont, 10126
Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma /ID# 260809
Verona, 37134
Ospedale Belcolle /ID# 259563
Viterbo, 01100
About this study
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
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.
Read more
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.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, Azacitidine, ABT-199, Cancer
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax + Azacitidine Participants | Participants treated with venetoclax in combination with azacitidine in accordance with approved local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as time from treatment initiation to death from any cause.
Measured: Up to 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Mar 2024
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058741
- Sponsor's protocol ID
- P23-498
- Acronym
- VERO
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06058741
- Acronym / sponsor ID
- VERO / P23-498
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, Azacitidine, ABT-199, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax + Azacitidine Participants | – | –Participants treated with venetoclax in combination with azacitidine in accordance with approved local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: Up to 18 Months
OS is defined as time from treatment initiation to death from any cause.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myeloid Leukemia
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Active, not recruitingPhase 2
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RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by AbbVie at 28 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.