VYxeoS Liposomal Italian Observational Study iN the Real Practice (VYSION)

November 17, 2025 updated by: Jazz Pharmaceuticals
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
      • Bergamo, Italy, 24127
        • Ospedale Papa Giovanni Xxiii
      • Bologna, Italy, 40138
        • Policlinico Sant'Orsola
      • Bolzano, Italy, 39100
        • Ospedale di Bolzano
      • Busto Arsizio, Italy, 21052
        • Ospedale Busto Arsizio
      • Castelfranco Veneto, Italy, 31033
        • Istituto Oncologico Veneto
      • Florence, Italy, 50134
        • Ospedale Careggi
      • Genova, Italy, 16132
        • Policlinico San Martino
      • Lecce, Italy, 73100
        • Ospedale Vito Fazzi
      • Milan, Italy, 20127
        • Policlinico di Milano Ospedale Maggiore
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Napoli, Italy, 80131
        • Ospedale Cardarelli
      • Palermo, Italy, 90146
        • Ospedali Riuniti Villa Sofia Cervello
      • Pescara, Italy, 65124
        • Ospedale Civile Santo Spirito
      • Pisa, Italy, 56126
        • Ospedale Santa Chiara
      • Ravenna, Italy, 48100
        • Ospedale di Ravenna
      • Reggio Calabria, Italy, 89124
        • Ospedale Bianchi Melacrino Morelli
      • Roma, Italy, 00133
        • Policlinico Tor Vergata
      • Roma, Italy, 00161
        • Policlinico Umberto I
      • Roma, Italy, 00168
        • Policlinico Agostino Gemelli
      • Roma, Italy, 00144
        • Ospedale Sant'Eugenio
      • Torino, Italy, 10126
        • Policlinico Molinette
      • Torrette Ancona, Italy, 60126
        • Ospedale Riuniti Marche Nord
      • Trieste, Italy, 34129
        • Ospedale di Trieste

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion criteria:

  • 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).

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Vyxeos liposomal
Standard of care JZP351 administered intravenously over 90 minutes.
Other Names:
  • CPX-351
  • JZP351

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment
Time Frame: Up to 24 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) after induction phase
Time Frame: Up to 24 months
ORR is the rate of participants achieving CR, CRi and CRh after induction phase
Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD after induction phase
Time Frame: Up to 24 months
MRD will be assessed via multiparameter flow cytometry.
Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD before transplantation
Time Frame: Up to 24 months
MRD will be assessed via multiparameter flow cytometry.
Up to 24 months
Overall survival (OS)
Time Frame: Up to 24 months
Overall survival is date from the start of taking Vyxeos liposomal (JZP351) to the date of reported death due to any cause.
Up to 24 months
Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)
Time Frame: Up to 24 months
Up to 24 months
Landmark overall survival (OS) from the time of HSCT
Time Frame: Up to 24 months
Up to 24 months
Percentage of participants with Adverse Events (AE)
Time Frame: Up to 24 months
Percentage of participants who experience Grades 1-5 and grade 3-5 adverse events, including AEs of special interest and serious AEs (SAEs), as evaluated by treating physician.
Up to 24 months
Percentage of participants with a change in fitness status as assessed by Ferrara criteria before HSCT
Time Frame: Up to 24 months
Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.
Up to 24 months
Percentage of participants with a change in fitness status as assessed by Ferrara criteria at the final treatment visit for patients not eligible for HSCT
Time Frame: Up to 24 months
Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Advice Pharma S.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JZP351-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings