VYxeoS Liposomal Italian Observational Study iN the Real Practice (VYSION)

May 6, 2024 updated by: Jazz Pharmaceuticals
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
      • Bergamo, Italy, 24127
        • Recruiting
        • Ospedale Papa Giovanni Xxiii
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico Sant'Orsola
      • Bolzano, Italy, 39100
        • Recruiting
        • Ospedale di Bolzano
      • Busto Arsizio, Italy, 21052
        • Recruiting
        • Ospedale Busto Arsizio
      • Castelfranco Veneto, Italy, 31033
        • Recruiting
        • Istituto Oncologico Veneto
      • Firenze, Italy, 50134
        • Recruiting
        • Ospedale Careggi
      • Genova, Italy, 16132
        • Recruiting
        • Policlinico San Martino
      • Lecce, Italy, 73100
        • Recruiting
        • Ospedale Vito Fazzi
      • Milano, Italy, 20127
        • Recruiting
        • Policlinico di Milano Ospedale Maggiore
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
      • Palermo, Italy, 90146
        • Recruiting
        • Ospedali Riuniti Villa Sofia Cervello
      • Pescara, Italy, 65124
        • Recruiting
        • Ospedale Civile Santo Spirito
      • Pisa, Italy, 56126
        • Recruiting
        • Ospedale Santa Chiara
      • Ravenna, Italy, 48100
        • Recruiting
        • Ospedale di Ravenna
      • Roma, Italy, 00168
        • Recruiting
        • Policlinico Agostino Gemelli
      • Roma, Italy, 00133
        • Recruiting
        • Policlinico Tor Vergata
      • Roma, Italy, 00161
        • Recruiting
        • Policlinico Umberto I
      • Rpma, Italy, 00144
        • Recruiting
        • Ospedale Sant'Eugenio
      • Torino, Italy, 10126
        • Recruiting
        • Policlinico Molinette
      • Torrette Ancona, Italy, 60126
        • Recruiting
        • Ospedale Riuniti Marche Nord
      • Trieste, Italy, 34129
        • Recruiting
        • Ospedale di Trieste

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults with t-AML or AML-MRC considered suitable for intensive chemotherapy who will be receiving JZP351 (Vyxeos liposomal) as part of their normal clinical care in Italian hematology centers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Vyxeos liposomal
Standard of care JZP351 administered intravenously over 90 minutes.
Other Names:
  • CPX-351
  • JZP351

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 months
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.
Up to 24 months
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.
Up to 24 months
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.
Up to 24 months
Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)
Time Frame: Up to 24 months
Up to 24 months
Landmark overall survival (OS) from the time of HSCT
Time Frame: Up to 24 months
Up to 24 months
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.
Up to 24 months
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.
Up to 24 months
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Collaborators

Advice Pharma S.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2023

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JZP351-501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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