Real-World italian study tracks vyxeos Liposomal's impact on Tough-to-Treat AML
NCT ID NCT06143839
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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113 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Oct 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
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Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
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Istituto Oncologico Veneto
Castelfranco Veneto, 31033, Italy
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Ospedale Bianchi Melacrino Morelli
Reggio Calabria, 89124, Italy
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Ospedale Busto Arsizio
Busto Arsizio, 21052, Italy
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Ospedale Cardarelli
Naples, 80131, Italy
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Ospedale Careggi
Florence, 50134, Italy
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Ospedale Civile Santo Spirito
Pescara, 65124, Italy
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Ospedale Papa Giovanni XXIII
Bergamo, 24127, Italy
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Ospedale Riuniti Marche Nord
Torrette Ancona, 60126, Italy
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Ospedale Sant'Eugenio
Roma, 00144, Italy
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Ospedale Santa Chiara
Pisa, 56126, Italy
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Ospedale Vito Fazzi
Lecce, 73100, Italy
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Ospedale di Bolzano
Bolzano, 39100, Italy
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Ospedale di Ravenna
Ravenna, 48100, Italy
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Ospedale di Trieste
Trieste, 34129, Italy
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Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146, Italy
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Policlinico Agostino Gemelli
Roma, 00168, Italy
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Policlinico Molinette
Torino, 10126, Italy
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Policlinico San Martino
Genova, 16132, Italy
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Policlinico Sant'Orsola
Bologna, 40138, Italy
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Policlinico Tor Vergata
Roma, 00133, Italy
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Policlinico Umberto I
Roma, 00161, Italy
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Policlinico di Milano Ospedale Maggiore
Milan, 20127, Italy
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Other studies related to the condition(s) this trial covers.
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- Can an Anti-Inflammation drug make AML chemotherapy work better?
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- Can engineered cells beat relapsed blood cancers?