VYxeoS Liposomal Italian Observational Study iN the Real Practice
NCT ID: NCT06143839
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
113 participants
OBSERVATIONAL
2023-12-07
2025-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Vyxeos liposomal
Standard of care JZP351 administered intravenously over 90 minutes.
Interventions
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Vyxeos liposomal
Standard of care JZP351 administered intravenously over 90 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Advice Pharma S.r.l.
UNKNOWN
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Ospedale Papa Giovanni XXIII
Bergamo, , Italy
Policlinico Sant'Orsola
Bologna, , Italy
Ospedale di Bolzano
Bolzano, , Italy
Ospedale Busto Arsizio
Busto Arsizio, , Italy
Istituto Oncologico Veneto
Castelfranco Veneto, , Italy
Ospedale Careggi
Florence, , Italy
Policlinico San Martino
Genova, , Italy
Ospedale Vito Fazzi
Lecce, , Italy
Policlinico di Milano Ospedale Maggiore
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Ospedale Cardarelli
Napoli, , Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo, , Italy
Ospedale Civile Santo Spirito
Pescara, , Italy
Ospedale Santa Chiara
Pisa, , Italy
Ospedale di Ravenna
Ravenna, , Italy
Ospedale Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Policlinico Tor Vergata
Roma, , Italy
Ospedale Sant'Eugenio
Roma, , Italy
Policlinico Umberto I
Roma, , Italy
Policlinico Agostino Gemelli
Roma, , Italy
Policlinico Molinette
Torino, , Italy
Ospedale Riuniti Marche Nord
Torrette Ancona, , Italy
Ospedale di Trieste
Trieste, , Italy
Countries
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Other Identifiers
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JZP351-501
Identifier Type: -
Identifier Source: org_study_id
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