VYxeoS Liposomal Italian Observational Study iN the Real Practice
VYSION
1 other identifier
observational
113
1 country
24
Brief Summary
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.
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 Dec 2023
24 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
November 16, 2023
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedStudy Start
First participant enrolled
December 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2025
CompletedNovember 20, 2025
November 1, 2025
1.9 years
November 16, 2023
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment
Percentage of participants showing CR (Complete Remission) / CRi (Complete Response with incomplete platelet or neutrophil recovery) /CRh (Complete Response with partial hematologic recovery) without MRD (measurable residual disease) at the end of treatment. MRD will be assessed via multiparameter flow cytometry.
Up to 24 months
Secondary Outcomes (9)
Overall Response Rate (ORR) after induction phase
Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD after induction phase
Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD before transplantation
Up to 24 months
Overall survival (OS)
Up to 24 months
Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)
Up to 24 months
- +4 more secondary outcomes
Study Arms (1)
Acute Myeloid Leukemia (AML)
Participants with newly diagnosed AML-MRC (Acute myeloid leukemia with myelodysplasia-related changes) or t-related AML (Therapy related Acute myeloid leukemia) receiving Vyxeos liposomal as part of their standard of care treatment.
Interventions
Standard of care JZP351 administered intravenously over 90 minutes.
Eligibility Criteria
Adults with t-AML or AML-MRC considered suitable for intensive chemotherapy who will be receiving JZP351 (Vyxeos liposomal) as part of their normal clinical care in Italian hematology centers.
You may qualify if:
- 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).
You may not qualify if:
- 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)
- Clinical evidence of active CNS (Central Nervous System) leukemia.
- Patients with active (uncontrolled, metastatic) second malignancies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jazz Pharmaceuticalslead
- Advice Pharma S.r.l.collaborator
Study Sites (24)
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
Ospedale Papa Giovanni XXIII
Bergamo, 24127, Italy
Policlinico Sant'Orsola
Bologna, 40138, Italy
Ospedale di Bolzano
Bolzano, 39100, Italy
Ospedale Busto Arsizio
Busto Arsizio, 21052, Italy
Istituto Oncologico Veneto
Castelfranco Veneto, 31033, Italy
Ospedale Careggi
Florence, 50134, Italy
Policlinico San Martino
Genova, 16132, Italy
Ospedale Vito Fazzi
Lecce, 73100, Italy
Policlinico di Milano Ospedale Maggiore
Milan, 20127, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Ospedale Cardarelli
Napoli, 80131, Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146, Italy
Ospedale Civile Santo Spirito
Pescara, 65124, Italy
Ospedale Santa Chiara
Pisa, 56126, Italy
Ospedale di Ravenna
Ravenna, 48100, Italy
Ospedale Bianchi Melacrino Morelli
Reggio Calabria, 89124, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Ospedale Sant'Eugenio
Roma, 00144, Italy
Policlinico Umberto I
Roma, 00161, Italy
Policlinico Agostino Gemelli
Roma, 00168, Italy
Policlinico Molinette
Torino, 10126, Italy
Ospedale Riuniti Marche Nord
Torrette Ancona, 60126, Italy
Ospedale di Trieste
Trieste, 34129, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2023
First Posted
November 22, 2023
Study Start
December 7, 2023
Primary Completion
October 23, 2025
Study Completion
October 23, 2025
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share