Trial Title:
VYxeoS Liposomal Italian Observational Study iN the Real Practice
NCT ID:
NCT06143839
Condition:
Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Therapy-Related Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Conditions: Keywords:
JZP351
CPX-351
Vyxeos liposomal
AML
t-related AML
AML-MRC
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Vyxeos liposomal
Description:
Standard of care JZP351 administered intravenously over 90 minutes.
Arm group label:
Acute Myeloid Leukemia (AML)
Other name:
JZP351
Other name:
CPX-351
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Address:
City:
Alessandria
Zip:
15121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Papa Giovanni XXIII
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Sant'Orsola
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale di Bolzano
Address:
City:
Bolzano
Zip:
39100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Busto Arsizio
Address:
City:
Busto Arsizio
Zip:
21052
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Oncologico Veneto
Address:
City:
Castelfranco Veneto
Zip:
31033
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Careggi
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Vito Fazzi
Address:
City:
Lecce
Zip:
73100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico di Milano Ospedale Maggiore
Address:
City:
Milano
Zip:
20127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Federico II
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Cardarelli
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedali Riuniti Villa Sofia Cervello
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Civile Santo Spirito
Address:
City:
Pescara
Zip:
65124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Chiara
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale di Ravenna
Address:
City:
Ravenna
Zip:
48100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Bianchi Melacrino Morelli
Address:
City:
Reggio Calabria
Zip:
89124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Tor Vergata
Address:
City:
Roma
Zip:
00133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Sant'Eugenio
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Umberto I
Address:
City:
Roma
Zip:
00161
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Agostino Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera "G. Brotzu"
Address:
City:
Selargius
Zip:
09047
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Molinette
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Riuniti Marche Nord
Address:
City:
Torrette Ancona
Zip:
60126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale di Trieste
Address:
City:
Trieste
Zip:
34129
Country:
Italy
Status:
Recruiting
Start date:
December 7, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Jazz Pharmaceuticals
Agency class:
Industry
Collaborator:
Agency:
Advice Pharma S.r.l.
Agency class:
Other
Source:
Jazz Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06143839
