VYxeoS Liposomal Italian Observational Study iN the Real Practice

Last updated: March 17, 2025
Sponsor: Jazz Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Acute Myelogenous Leukemia (Aml)

White Cell Disorders

Leukemia (Pediatric)

Treatment

Vyxeos liposomal

Clinical Study ID

NCT06143839
JZP351-501
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Patients newly diagnosed with AML-MRC (Acute myeloid leukemia withmyelodysplasia-related changes) or t-related AML (Therapy related Acute myeloidleukemia) following 2016 World Health Organization (WHO) classification.

  • Age ≥ 18 years old.

  • Patients considered eligible for intensive chemotherapy in the opinion of thetreating physician.

  • Patients who will initiate the treatment with commercially JZP351 treatment afterthe Informed Consent Form (ICF) signature. The decision to prescribe JZP351treatment must have been made prior and regardless of the enrollment of the patientin the study.

  • Cardiac ejection fraction ≥ 50% by echocardiography or MUGA (Multi-GatedAcquisition).

Exclusion

Exclusion criteria:

  • Prior treatment intended for induction therapy of AML (Acute Myeloid Leukemia).

  • Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2daunorubicin (or equivalent)

  • Clinical evidence of active CNS (Central Nervous System) leukemia.

  • Patients with active (uncontrolled, metastatic) second malignancies.

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: Vyxeos liposomal
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
February 01, 2026

Connect with a study center

  • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121
    Italy

    Site Not Available

  • Ospedale Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Policlinico Sant'Orsola

    Bologna, 40138
    Italy

    Site Not Available

  • Ospedale di Bolzano

    Bolzano, 39100
    Italy

    Site Not Available

  • Ospedale Busto Arsizio

    Busto Arsizio, 21052
    Italy

    Site Not Available

  • Istituto Oncologico Veneto

    Castelfranco Veneto, 31033
    Italy

    Site Not Available

  • Ospedale Careggi

    Firenze, 50134
    Italy

    Site Not Available

  • Policlinico San Martino

    Genova, 16132
    Italy

    Site Not Available

  • Ospedale Vito Fazzi

    Lecce, 73100
    Italy

    Site Not Available

  • Policlinico di Milano Ospedale Maggiore

    Milano, 20127
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • Ospedale Cardarelli

    Napoli, 80131
    Italy

    Site Not Available

  • Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Ospedale Civile Santo Spirito

    Pescara, 65124
    Italy

    Site Not Available

  • Ospedale Santa Chiara

    Pisa, 56126
    Italy

    Site Not Available

  • Ospedale di Ravenna

    Ravenna, 48100
    Italy

    Site Not Available

  • Ospedale Bianchi Melacrino Morelli

    Reggio Calabria, 89124
    Italy

    Site Not Available

  • Ospedale Sant'Eugenio

    Roma, 00144
    Italy

    Site Not Available

  • Policlinico Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Policlinico Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • Policlinico Umberto I

    Roma, 00161
    Italy

    Site Not Available

  • Ospedale Sant'Eugenio

    Rpma, 00144
    Italy

    Site Not Available

  • Azienda Ospedaliera "G. Brotzu"

    Selargius, 09047
    Italy

    Site Not Available

  • Policlinico Molinette

    Torino, 10126
    Italy

    Site Not Available

  • Ospedale Riuniti Marche Nord

    Torrette Ancona, 60126
    Italy

    Site Not Available

  • Ospedale di Trieste

    Trieste, 34129
    Italy

    Site Not Available

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