CPX-351 Real-World Effectiveness and Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-06-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

CPX-351

Intervention Type DRUG

This is a retrospective, non-interventional, observational study. No study drug will be administered in this study.

Interventions

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CPX-351

This is a retrospective, non-interventional, observational study. No study drug will be administered in this study.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No