Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, CPX-351, Vyxeos liposomal
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).
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.
Interventions
DRUGCPX-351
This is a retrospective, non-interventional, observational study. No study drug will be administered in this study.
Sponsors
Iqvia Pty Ltd
Jazz Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed