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| Name | Class |
|---|---|
| Advice Pharma S.r.l. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vyxeos liposomal | Drug | Standard of care JZP351 administered intravenously over 90 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of participants showing CR/CRi/CRh without MRD after induction phase |
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Inclusion criteria:
Exclusion criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | 15121 | Italy | |||
| Ospedale Papa Giovanni XXIII |
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MRD will be assessed via multiparameter flow cytometry.
| Up to 24 months |
| Percentage of participants showing CR/CRi/CRh without MRD before transplantation | MRD will be assessed via multiparameter flow cytometry. | 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. | Up to 24 months |
| Percentage of participants receiving an Hematopoietic stem-cell transplantation (HSCT) | Up to 24 months |
| Landmark overall survival (OS) from the time of HSCT | Up to 24 months |
| 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 |
| 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 |
| 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 |
| Bergamo |
| 24127 |
| Italy |
| Policlinico Sant'Orsola | Bologna | 40138 | Italy |
| Ospedale di Bolzano | Bolzano | 39100 | Italy |
| Ospedale Busto Arsizio | Busto Arsizio | 21052 | Italy |
| Istituto Oncologico Veneto | Castelfranco Veneto | 31033 | Italy |
| Ospedale Careggi | Florence | 50134 | Italy |
| Policlinico San Martino | Genova | 16132 | Italy |
| Ospedale Vito Fazzi | Lecce | 73100 | Italy |
| Policlinico di Milano Ospedale Maggiore | Milan | 20127 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Ospedale Cardarelli | Naples | 80131 | Italy |
| Ospedali Riuniti Villa Sofia Cervello | Palermo | 90146 | Italy |
| Ospedale Civile Santo Spirito | Pescara | 65124 | Italy |
| Ospedale Santa Chiara | Pisa | 56126 | Italy |
| Ospedale di Ravenna | Ravenna | 48100 | Italy |
| Ospedale Bianchi Melacrino Morelli | Reggio Calabria | 89124 | Italy |
| Policlinico Tor Vergata | Roma | 00133 | Italy |
| Ospedale Sant'Eugenio | Roma | 00144 | Italy |
| Policlinico Umberto I | Roma | 00161 | Italy |
| Policlinico Agostino Gemelli | Roma | 00168 | Italy |
| Policlinico Molinette | Torino | 10126 | Italy |
| Ospedale Riuniti Marche Nord | Torrette Ancona | 60126 | Italy |
| Ospedale di Trieste | Trieste | 34129 | Italy |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000629812 | CPX-351 |
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