CPX-351 Real-World Effectiveness and Safety Study

Jazz Pharmaceuticals

Status: Completed

Conditions: Acute Myeloid Leukemia

Treatments: Drug: CPX-351

Study type: Observational

Funder types: Industry

Identifiers

NCT05169307

CREST UK

Details and patient eligibility

About

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).

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

147 participants in 1 patient group

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.

Treatment:

Drug: CPX-351