NCT06143839Completed
VYxeoS Liposomal Italian Observational Study iN the Real Practice
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
The study is a prospective, single-arm, non-experimental, observational study in patients in Italy with Acute Myeloid Leukaemia (AML) with myelodysplastic-related changes or therapy related AML initiating treatment with JZP351 (Vyxeos liposomal) in their normal clinical practice.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 113 (actual)
- First submitted
- 16 Nov 2023
- Start date
- 7 Dec 2023
- Primary completion date
- 23 Oct 2025
- Lead sponsor
- Jazz Pharmaceuticals
- NCT number
- NCT06143839
What you commit to
- Study type: Observational
- Participants enrolled: 113
- From 7 Dec 2023 to the primary completion date, 23 Oct 2025
- 24 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 intended for induction therapy of AML (Acute Myeloid Leukemia).
- Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
Other illness
- Patients with active (uncontrolled, metastatic) second malignancies.
Other
- Clinical evidence of active CNS (Central Nervous System) leukemia.
Who the study is looking for
- Patients newly diagnosed with AML-MRC (Acute myeloid leukemia with myelodysplasia-related changes) or t-related AML (Therapy related Acute myeloid leukemia) following 2016 World Health Organization (WHO) classification.
- Age ≥ 18 years old.
- Patients considered eligible for intensive chemotherapy in the opinion of the treating physician.
- Patients who will initiate the treatment with commercially JZP351 treatment after the Informed Consent Form (ICF) signature. The decision to prescribe JZP351 treatment must have been made prior and regardless of the enrollment of the patient in the study.
- Cardiac ejection fraction ≥ 50% by echocardiography or MUGA (Multi-Gated Acquisition).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo Coordinator of this site? Confirm its status | Alessandria | Italy | Unknown status |
| Ospedale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Policlinico Sant'Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Ospedale di Bolzano Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| Ospedale Busto Arsizio Coordinator of this site? Confirm its status | Busto Arsizio | Italy | Unknown status |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Castelfranco Veneto | Italy | Unknown status |
| Ospedale Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Ospedale Vito Fazzi Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Policlinico di Milano Ospedale Maggiore Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ospedale Civile Santo Spirito Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Ospedale Santa Chiara Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Ospedale di Ravenna Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| Ospedale Bianchi Melacrino Morelli Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Unknown status |
| Policlinico Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale Sant'Eugenio Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Molinette Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Ospedale Riuniti Marche Nord Coordinator of this site? Confirm its status | Torrette Ancona | Italy | Unknown status |
| Ospedale di Trieste Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.