Acute Myeloid Leukemia (AML)VYSIONNCT06143839
VYxeoS Liposomal Italian Observational Study iN the Real Practice
An observational study of Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With Myelodysplasia-Related Changes, run by Jazz Pharmaceuticals at 24 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
- What is being tested?
- Vyxeos liposomal
- Type of treatment
- Injection or infusion
- How many people
- 113 participants
- Where
- 24 sitesItaly
- Study dates
- 7 Dec 2023to 23 Oct 2025
- 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: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Italy24 sites
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Ospedale Papa Giovanni XXIII
Bergamo, 24127
Policlinico Sant'Orsola
Bologna, 40138
Ospedale di Bolzano
Bolzano, 39100
Ospedale Busto Arsizio
Busto Arsizio, 21052
Istituto Oncologico Veneto
Castelfranco Veneto, 31033
Ospedale Careggi
Florence, 50134
Policlinico San Martino
Genova, 16132
Ospedale Vito Fazzi
Lecce, 73100
Policlinico di Milano Ospedale Maggiore
Milan, 20127
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Ospedale Cardarelli
Naples, 80131
Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146
Ospedale Civile Santo Spirito
Pescara, 65124
Ospedale Santa Chiara
Pisa, 56126
Ospedale di Ravenna
Ravenna, 48100
Ospedale Bianchi Melacrino Morelli
Reggio Calabria, 89124
Policlinico Tor Vergata
Roma, 00133
Ospedale Sant'Eugenio
Roma, 00144
Policlinico Umberto I
Roma, 00161
Policlinico Agostino Gemelli
Roma, 00168
Policlinico Molinette
Torino, 10126
Ospedale Riuniti Marche Nord
Torrette Ancona, 60126
Ospedale di Trieste
Trieste, 34129
About this study
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.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
- Being tested
- Vyxeos liposomal
- Keywords
- JZP351, CPX-351, Vyxeos liposomal, AML, t-related AML, AML-MRC
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vyxeos liposomalDrug
Also called JZP351, CPX-351
Standard of care JZP351 administered intravenously over 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vyxeos liposomal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (9)
Overall Response Rate (ORR) after induction phase
ORR is the rate of participants achieving CR, CRi and CRh after induction phase
Measured: Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD after induction phase
MRD will be assessed via multiparameter flow cytometry.
Measured: Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD before transplantation
MRD will be assessed via multiparameter flow cytometry.
Measured: Up to 24 months
Overall survival (OS)
Overall survival is date from the start of taking Vyxeos liposomal (JZP351) to the date of reported death due to any cause.
Measured: Up to 24 months
Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)
Measured: Up to 24 months
Landmark overall survival (OS) from the time of HSCT
Measured: Up to 24 months
Percentage of participants with Adverse Events (AE)
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.
Measured: Up to 24 months
Percentage of participants with a change in fitness status as assessed by Ferrara criteria before HSCT
Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.
Measured: 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
Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start7 Dec 2023
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advice Pharma S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143839
- Sponsor's protocol ID
- JZP351-501
- Acronym
- VYSION
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VYxeoS Liposomal Italian Observational Study iN the Real Practice
- ClinicalTrials.gov ID
- NCT06143839
- Acronym / sponsor ID
- VYSION / JZP351-501
- Conditions
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
- Keywords
- JZP351, CPX-351, Vyxeos liposomal, AML, t-related AML, AML-MRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Advice Pharma S.r.l.
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 22 Nov 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Myeloid Leukemia (AML) | – | Drug: Vyxeos liposomalParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vyxeos liposomalAlso: JZP351, CPX-351Standard of care JZP351 administered intravenously over 90 minutes. | Drug | Acute Myeloid Leukemia (AML) |
Primary outcome
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.
9 secondary outcomes
Overall Response Rate (ORR) after induction phase
Time frame: Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD after induction phase
Time frame: Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD before transplantation
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)
Time frame: Up to 24 months
Landmark overall survival (OS) from the time of HSCT
Time frame: Up to 24 months
Percentage of participants with Adverse Events (AE)
Time frame: 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
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
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 20 Nov 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 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 (AML) and Acute Myeloid Leukemia With Myelodysplasia-Related Changes, run by Jazz Pharmaceuticals at 24 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 5 inclusion and 4 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment (time frame: Up to 24 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 20 Nov 2025.