VYxeoS Liposomal Italian Observational Study iN the Real Practice
- Conditions
- Therapy-Related Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML)Acute Myeloid Leukemia With Myelodysplasia-Related Changes
- Interventions
- Registration Number
- NCT06143839
- Lead Sponsor
- Jazz Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute Myeloid Leukemia (AML) Vyxeos liposomal 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.
- Primary Outcome Measures
Name Time Method Percentage of participants showing CR/CRi/CRh without MRD at the end of treatment 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.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) after induction phase Up to 24 months ORR is the rate of participants achieving CR, CRi and CRh after induction phase
Landmark overall survival (OS) from the time of HSCT 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 Up to 24 months Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.
Percentage of participants showing CR/CRi/CRh without MRD after induction phase Up to 24 months MRD will be assessed via multiparameter flow cytometry.
Percentage of participants with a change in fitness status as assessed by Ferrara criteria before HSCT Up to 24 months Ferrara criteria is a list of assessments evaluating whether a participant is eligible for intensive chemotherapy or not.
Percentage of participants showing CR/CRi/CRh without MRD before transplantation Up to 24 months MRD will be assessed via multiparameter flow cytometry.
Overall survival (OS) 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.
Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT) Up to 24 months Percentage of participants with Adverse Events (AE) 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.
Trial Locations
- Locations (24)
Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Ospedale Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale di Bolzano
🇮🇹Bolzano, Italy
Ospedale Busto Arsizio
🇮🇹Busto Arsizio, Italy
Istituto Oncologico Veneto
🇮🇹Castelfranco Veneto, Italy
Policlinico Sant'Orsola
🇮🇹Bologna, 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
Ospedale Cardarelli
🇮🇹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 Tor Vergata
🇮🇹Roma, Italy
Ospedale Sant'Eugenio
🇮🇹Roma, Italy
Policlinico Umberto I
🇮🇹Roma, Italy
Policlinico Agostino Gemelli
🇮🇹Roma, Italy
Policlinico Molinette
🇮🇹Torino, Italy
Ospedale Riuniti Marche Nord
🇮🇹Torrette Ancona, Italy
Ospedale di Trieste
🇮🇹Trieste, Italy