Clinical trial · Observational
CPX-351 Real-World Effectiveness and Safety Study
CREST UK: CPX-351 Real-World Effectiveness and Safety Study
NCT05169307CI-TRIAL-00059606completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPX-351 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CPX-351
- description
- 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.
- interventionNames
- Drug: CPX-351
Primary outcomes (2)
- measure
- 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
- timeFrame
- First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months
- measure
- Overall Survival in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal
- timeFrame
- First infusion of Vyxeos liposomal (post-August 2018 approval) to date of death, up to approximately 3 years 4 months
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.