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Real-World italian study tracks vyxeos Liposomal's impact on Tough-to-Treat AML

NCT ID NCT06143839

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observed 113 adults in Italy with acute myeloid leukemia (AML) linked to prior cancer therapy or bone marrow problems. All participants received Vyxeos liposomal as part of their normal care. Researchers tracked how many achieved complete remission without detectable disease after treatment. The goal was to see how well the drug works outside of controlled clinical trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

113 people

The number who actually took part.

Started

Dec 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131, Italy

  • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121, Italy

  • Istituto Oncologico Veneto

    Castelfranco Veneto, 31033, Italy

  • Ospedale Bianchi Melacrino Morelli

    Reggio Calabria, 89124, Italy

  • Ospedale Busto Arsizio

    Busto Arsizio, 21052, Italy

  • Ospedale Cardarelli

    Naples, 80131, Italy

  • Ospedale Careggi

    Florence, 50134, Italy

  • Ospedale Civile Santo Spirito

    Pescara, 65124, Italy

  • Ospedale Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Ospedale Riuniti Marche Nord

    Torrette Ancona, 60126, Italy

  • Ospedale Sant'Eugenio

    Roma, 00144, Italy

  • Ospedale Santa Chiara

    Pisa, 56126, Italy

  • Ospedale Vito Fazzi

    Lecce, 73100, Italy

  • Ospedale di Bolzano

    Bolzano, 39100, Italy

  • Ospedale di Ravenna

    Ravenna, 48100, Italy

  • Ospedale di Trieste

    Trieste, 34129, Italy

  • Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146, Italy

  • Policlinico Agostino Gemelli

    Roma, 00168, Italy

  • Policlinico Molinette

    Torino, 10126, Italy

  • Policlinico San Martino

    Genova, 16132, Italy

  • Policlinico Sant'Orsola

    Bologna, 40138, Italy

  • Policlinico Tor Vergata

    Roma, 00133, Italy

  • Policlinico Umberto I

    Roma, 00161, Italy

  • Policlinico di Milano Ospedale Maggiore

    Milan, 20127, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.