VYxeoS Liposomal Italian Observational Study iN the Real Practice

Acute Myeloid Leukemia (AML) Clinical Trial

— VYSION  

Official title:

VYxeoS Liposomal Italian Observational Study iN the Real Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143839
• Other study ID #: JZP351-501
• Status: Recruiting
• Start date: December 7, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: May 2024
• Source: Jazz Pharmaceuticals
• Contact: Clinical Trial Disclosure & Transparency
• Phone: 215-832-3750
• Email: ClinicalTrialDisclosure[@]JazzPharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Acute Myeloid Leukemia With Myelodysplasia-Related Changes
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Therapy-Related Acute Myeloid Leukemia

Intervention

Drug:
• Vyxeos liposomal
Standard of care JZP351 administered intravenously over 90 minutes.

Locations

Country	Name	City	State
Italy	Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Ospedale Papa Giovanni XXIII	Bergamo
Italy	Policlinico Sant'Orsola	Bologna
Italy	Ospedale di Bolzano	Bolzano
Italy	Ospedale Busto Arsizio	Busto Arsizio
Italy	Istituto Oncologico Veneto	Castelfranco Veneto
Italy	Ospedale Careggi	Firenze
Italy	Policlinico San Martino	Genova
Italy	Ospedale Vito Fazzi	Lecce
Italy	Policlinico di Milano Ospedale Maggiore	Milano
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Ospedali Riuniti Villa Sofia Cervello	Palermo
Italy	Ospedale Civile Santo Spirito	Pescara
Italy	Ospedale Santa Chiara	Pisa
Italy	Ospedale di Ravenna	Ravenna
Italy	Ospedale Bianchi Melacrino Morelli	Reggio Calabria
Italy	Policlinico Agostino Gemelli	Roma
Italy	Policlinico Tor Vergata	Roma
Italy	Policlinico Umberto I	Roma
Italy	Ospedale Sant'Eugenio	Rpma
Italy	Policlinico Molinette	Torino
Italy	Ospedale Riuniti Marche Nord	Torrette Ancona
Italy	Ospedale di Trieste	Trieste

Sponsors (2)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals	Advice Pharma S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment	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	Overall Response Rate (ORR) after induction phase	ORR is the rate of participants achieving CR, CRi and CRh after induction phase	Up to 24 months
Secondary	Percentage of participants showing CR/CRi/CRh without MRD after induction phase	MRD will be assessed via multiparameter flow cytometry.	Up to 24 months
Secondary	Percentage of participants showing CR/CRi/CRh without MRD before transplantation	MRD will be assessed via multiparameter flow cytometry.	Up to 24 months
Secondary	Overall survival (OS)	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
Secondary	Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)		Up to 24 months
Secondary	Landmark overall survival (OS) from the time of HSCT		Up to 24 months
Secondary	Percentage of participants with Adverse Events (AE)	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
Secondary	Percentage of participants with a change in fitness status as assessed by Ferrara criteria before HSCT	Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.	Up to 24 months
Secondary	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	Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.	Up to 24 months