NCT06058741Completed
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
Venetoclax Real-World Observational Study on Effectiveness and Treatment Management in Patients With Newly Diagnosed AML Who Are Ineligible for Intensive Chemotherapy in Italy
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 151 (actual)
- First submitted
- 22 Sept 2023
- Start date
- Mar 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- AbbVie
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06058741
What you commit to
- Study type: Observational
- Participants enrolled: 151
- From Mar 2024 to the primary completion date, Jul 2026
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Participants affected by Acute Promyelocytic Leukemia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria delle Marche /ID# 261822 Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII /ID# 258727 Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 259535 Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833 Coordinator of this site? Confirm its status | Busto Arsizio | Italy | Unknown status |
| AOU Policlinico G. Rodolico - San Marco /ID# 261223 Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Careggi /ID# 259766 Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Ospedale San Martino /ID# 258981 Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Presidio Ospedaliero Vito Fazzi /ID# 261222 Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 260963 Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 259455 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 260738 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria di Modena /ID# 259189 Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 261794 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 259778 Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261146 Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo /ID# 259624 Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 258983 Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| AST Pesaro Urbino - P.O. San Salvatore - Stab. di Muraglia /ID# 261400 Coordinator of this site? Confirm its status | Pesaro | Italy | Unknown status |
| Azienda Sanitaria Locale Pescara-Presidio Ospedaliero S.Spirito /ID# 261304 Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 260737 Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260683 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 260821 Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| IRCCS Istituto Clinico Humanitas /ID# 259300 Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 259456 Coordinator of this site? Confirm its status | Salerno | Italy | Unknown status |
| Azienda Sanitaria Universitaria Giuliano Isontina /ID# 261298 Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258720 Coordinator of this site? Confirm its status | Turin | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma /ID# 260809 Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Ospedale Belcolle /ID# 259563 Coordinator of this site? Confirm its status | Viterbo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.