Clinical trial · Observational
VYxeoS Liposomal Italian Observational Study iN the Real Practice
NCT06143839CI-TRIAL-00097644VYSIONcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia With Myelodysplasia-Related Changes | Acute Myeloid Leukemia, Myelodysplasia-Related | ALIAS | 0.90 |
| Therapy-Related Acute Myeloid Leukemia | Acute Myeloid Leukemia Post Cytotoxic Therapy | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vyxeos liposomal | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Acute Myeloid Leukemia (AML)
- description
- 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.
- interventionNames
- Drug: Vyxeos liposomal
Primary outcomes (1)
- measure
- Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment
- timeFrame
- Up to 24 months
- description
- Percentage of participants showing CR (Complete Remission) / CRi (Complete Response with incomplete platelet or neutrophil recovery) /CRh (Complete Response with partial hematologic recovery) without MRD (measurable residual disease) at the end of treatment. MRD will be assessed via multiparameter flow cytometry.
Secondary outcomes (9)
- measure
- Overall Response Rate (ORR) after induction phase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.