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 Type
OBSERVATIONAL
Enrollment
113
Standard of care JZP351 administered intravenously over 90 minutes.
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Papa Giovanni XXIII
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.
Time frame: Up to 24 months
Overall Response Rate (ORR) after induction phase
ORR is the rate of participants achieving CR, CRi and CRh after induction phase
Time frame: Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD after induction phase
MRD will be assessed via multiparameter flow cytometry.
Time frame: Up to 24 months
Percentage of participants showing CR/CRi/CRh without MRD before transplantation
MRD will be assessed via multiparameter flow cytometry.
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT)
Time frame: Up to 24 months
Landmark overall survival (OS) from the time of HSCT
Time frame: Up to 24 months
Percentage of participants with Adverse Events (AE)
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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
Florence, Italy
Policlinico San Martino
Genova, Italy
Ospedale Vito Fazzi
Lecce, Italy
Policlinico di Milano Ospedale Maggiore
Milan, Italy
...and 14 more locations
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.
Time frame: Up to 24 months
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.
Time frame: 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
Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.
Time frame: Up to 24 months