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Completed

NCT Number: NCT06143839

VYxeoS Liposomal Italian Observational Study iN the Real Practice

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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Acute Myeloid Leukemia With Myelodysplasia-Related Changes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Therapy-Related Acute Myeloid Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vyxeos liposomal

Drug

Standard of care JZP351 administered intravenously over 90 minutes.

Other names: JZP351, CPX-351

Primary outcomes

  1. Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment

    Time frame: Up to 24 months

    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

  1. Overall Response Rate (ORR) after induction phase

    Time frame: Up to 24 months

    ORR is the rate of participants achieving CR, CRi and CRh after induction phase

  2. Percentage of participants showing CR/CRi/CRh without MRD after induction phase

    Time frame: Up to 24 months

    MRD will be assessed via multiparameter flow cytometry.

  3. Percentage of participants showing CR/CRi/CRh without MRD before transplantation

    Time frame: Up to 24 months

    MRD will be assessed via multiparameter flow cytometry.

  4. Overall survival (OS)

    Time frame: Up to 24 months

    Overall survival is date from the start of taking Vyxeos liposomal (JZP351) to the date of reported death due to any cause.

  5. Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)

    Time frame: Up to 24 months

  6. Landmark overall survival (OS) from the time of HSCT

    Time frame: Up to 24 months

  7. Percentage of participants with Adverse Events (AE)

    Time frame: Up to 24 months

    Percentage of participants who experience Grades 1-5 and grade 3-5 adverse events, including AEs of special interest and serious AEs (SAEs), as evaluated by treating physician.

  8. Percentage of participants with a change in fitness status as assessed by Ferrara criteria before HSCT

    Time frame: Up to 24 months

    Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.

  9. Percentage of participants with a change in fitness status as assessed by Ferrara criteria at the final treatment visit for patients not eligible for HSCT

    Time frame: Up to 24 months

    Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Collaborators

  • Advice Pharma S.r.l.

Registry information

Acronym: VYSION

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2023
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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