CREST UK: REAL-WORLD EFFECTIVENESS AND SAFETY STUDY
Research type
Research Study
Full title
CREST UK: CPX-351 REAL-WORLD EFFECTIVENESS AND SAFETY STUDY
IRAS ID
291998
Contact name
Priyanka Mehta
Contact email
Sponsor organisation
Jazz Pharmaceuticals
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Acute Myeloid Leukaemia (AML) is a cancer of white blood cells and represents a group of stem cell disorders. Untreated AML in all ages is rapidly fatal and even with treatment, some groups of AML patients continue to have poor outcomes.
Vyxeos liposomal is a cancer medicine used to treat adults with newly diagnosed AML and received approval from the European Medicines Agency and NICE in 2018 and then Scottish Medicines Consortium in 2019 shortly thereafter.
Since approval, the UK has significant experience of the use of Vyxeos liposomal outside of clinical trials. The generation of real-world evidence will provide data to complement the pivotal Clinical Trials and also add further knowledge in relation to the effectiveness and safety of Vyxeos liposomal.
The CREST UK study is therefore a RWE study designed to collect data on the potential benefits and/or risks of Vyxeos liposomal in routine clinical practice in the UK. The design of the study will be that of a retrospective medical chart review.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0040
Date of REC Opinion
5 Apr 2021
REC opinion
Favourable Opinion