Status:
COMPLETED
VYxeoS Liposomal Italian Observational Study iN the Real Practice
Lead Sponsor:
Jazz Pharmaceuticals
Collaborating Sponsors:
Advice Pharma S.r.l.
Conditions:
Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Eligibility:
All Genders
18+ years
Brief 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 initia...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 23 2025
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT06143839
Start Date
December 7 2023
End Date
October 23 2025
Last Update
November 20 2025
Active Locations (24)
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1
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
2
Ospedale Papa Giovanni XXIII
Bergamo, Italy, 24127
3
Policlinico Sant'Orsola
Bologna, Italy, 40138
4
Ospedale di Bolzano
Bolzano, Italy, 39100