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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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CPX-351 Real World Effectiveness and Safety Study (CREST UK) is a real-world evidence study designed to collect data on the potential benefits and/or risks of Vyxeos liposomal (liposomal daunorubicin/cytarabine; CPX-351) in routine clinical practice in the United Kingdom (UK).
This is a retrospective, non interventional, multi-centre, single arm, observational study designed to assess patients with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or acute myeloid leukaemia with myelodysplasia related changes (AML-MRC) who have been treated with Vyxeos liposomal (liposomal daunorubicin/cytarabine; CPX-351) in routine UK clinical practice and managed as per standard local practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPX-351 | Adult patients with newly diagnosed, therapy related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) who were treated in routine practice with Vyxeos liposomal in the UK. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPX-351 | Drug | This is a retrospective, non-interventional, observational study. No study drug will be administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Complete Response/Complete Response with Incomplete Platelet or Neutrophil Recovery in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal | First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months | |
| Overall Survival in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal | First infusion of Vyxeos liposomal (post-August 2018 approval) to date of death, up to approximately 3 years 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vyxeos Liposomal Induction and Consolidation Cycles Administered (Inpatient or Outpatient) in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal | First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months | |
| Dose Per Cycle of Vyxeos Liposomal Given During Induction and Consolidation Cycles Administered in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed, t-AML or AML-MRC who have been treated with Vyxeos liposomal in routine UK clinical practice and managed as per standard local practice will be enrolled in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast City Hospital | Belfast | BT9 7AB | United Kingdom | |||
| Bristol Royal Infirmary |
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| First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months |
| Percentage of Participants Transferred for Haematopoietic Stem Cell Transplant (HSCT) in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal | First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months |
| Overall Survival in Participants Post-HSCT With AML Who Were Treated in Routine Practice With Vyxeos Liposomal | Date of HSCT to date of death, up to approximately 3 years 4 months |
| Mean Duration of Hospitalization Stay of Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal | First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months |
| Bristol |
| BS2 8HW |
| United Kingdom |
| University Hospitals Derby and Burton | Derby | DE22 3NE | United Kingdom |
| Western General Hospital (Lothian) | Edinburgh | EH16 4TJ | United Kingdom |
| Royal Devon and Exeter | Exeter | EX2 5DW | United Kingdom |
| The Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| University College London Hospitals | London | NW1 2BU | United Kingdom |
| Royal Marsden | London | SW3 6JJ | United Kingdom |
| Royal Liverpool/Clatterbridge | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Peterborough Hospital | Peterborough | PE3 9GZ | United Kingdom |
| Queen Alexandra Hospital, Portsmouth | Portsmouth | PO6 3LY | United Kingdom |
| Torbay and South Devon | Torquay | TQ2 7AA | United Kingdom |
| New Cross Hospital - Wolverhampton | Wolverhampton | WV10 OQP | United Kingdom |
| 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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