Clinical trial NCT06143839: VYxeoS Liposomal Italian Observational Study iN the Real Practice
Official title: VYxeoS Liposomal Italian Observational Study iN the Real Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Therapy-Related Acute Myeloid Leukemia
Keywords: JZP351
CPX-351
Vyxeos liposomal
AML
t-related AML
AML-MRC
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Advice Pharma S.r.l.
First posted: 2023-11-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 initiating treatment with JZP351 (Vyxeos liposomal) in their normal clinical practice.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment
timeFrame: Up to 24 months
Secondary outcomes:
measure: Overall Response Rate (ORR) after induction phase
timeFrame: Up to 24 months
measure: Percentage of participants showing CR/CRi/CRh without MRD after induction phase
timeFrame: Up to 24 months
measure: Percentage of participants showing CR/CRi/CRh without MRD before transplantation
timeFrame: Up to 24 months
measure: Overall survival (OS)
timeFrame: Up to 24 months
measure: Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)
timeFrame: Up to 24 months
measure: Landmark overall survival (OS) from the time of HSCT
timeFrame: Up to 24 months
measure: Percentage of participants with Adverse Events (AE)
timeFrame: Up to 24 months
measure: Percentage of participants with a change in fitness status as assessed by Ferrara criteria before HSCT
timeFrame: Up to 24 months
measure: 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
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola
city: Bolzano
country: Italy
facility: Ospedale di Bolzano
city: Busto Arsizio
country: Italy
facility: Ospedale Busto Arsizio
city: Castelfranco Veneto
country: Italy
facility: Istituto Oncologico Veneto
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Genova
country: Italy
facility: Policlinico San Martino
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Milano
country: Italy
facility: Policlinico di Milano Ospedale Maggiore
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia Cervello
city: Pescara
country: Italy
facility: Ospedale Civile Santo Spirito
city: Pisa
country: Italy
facility: Ospedale Santa Chiara
city: Ravenna
country: Italy
facility: Ospedale di Ravenna
city: Reggio Calabria
country: Italy
facility: Ospedale Bianchi Melacrino Morelli
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Ospedale Sant'Eugenio
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Torino
country: Italy
facility: Policlinico Molinette
city: Torrette Ancona
country: Italy
facility: Ospedale Riuniti Marche Nord
city: Trieste
country: Italy
facility: Ospedale di Trieste
Study officials:
References: