CPX-351 Real-World Effectiveness and Safety Study
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: CPX-351
This is a retrospective, non-interventional, observational study. No study drug will be administered in this study.
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged ≥18 years at the start of treatment of AML with Vyxeos liposomal
-
Pathological diagnosis of t-AML or AML-MRC according to World Health Organization criteria (with at least 20% blasts in the peripheral blood or bone marrow)
-
Patient has received at least one infusion of Vyxeos liposomal, prescribed as per the SmPC
-
Patient signs an informed consent form or is included in accordance with an informed consent waiver
Exclusion Criteria:
-
Treatment with Vyxeos liposomal as part of a clinical trial or managed access program
-
Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Belfast City Hospital | Belfast | United Kingdom | BT9 7AB | |
| 2 | Bristol Royal Infirmary | Bristol | United Kingdom | BS2 8HW | |
| 3 | University Hospitals Derby and Burton | Derby | United Kingdom | DE22 3NE | |
| 4 | Western General Hospital (Lothian) | Edinburgh | United Kingdom | EH16 4TJ | |
| 5 | Royal Devon and Exeter | Exeter | United Kingdom | EX2 5DW | |
| 6 | The Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom | LS9 7TF | |
| 7 | Leicester Royal Infirmary | Leicester | United Kingdom | LE1 5WW | |
| 8 | University College London Hospitals | London | United Kingdom | NW1 2BU | |
| 9 | Royal Marsden | London | United Kingdom | SW3 6JJ | |
| 10 | James Cook University Hospital | Middlesbrough | United Kingdom | TS4 3BW | |
| 11 | Peterborough Hospital | Peterborough | United Kingdom | PE3 9GZ | |
| 12 | Queen Alexandra Hospital, Portsmouth | Portsmouth | United Kingdom | PO6 3LY | |
| 13 | Torbay and South Devon | Torquay | United Kingdom | TQ2 7AA | |
| 14 | Royal Liverpool/Clatterbridge | Wirral | United Kingdom | CH63 4JY | |
| 15 | New Cross Hospital - Wolverhampton | Wolverhampton | United Kingdom | WV10 OQP |
Sponsors and Collaborators
- Jazz Pharmaceuticals
- Iqvia Pty Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CREST UK