CPX-351 Real-World Effectiveness and Safety Study

July 8, 2022 updated by: Jazz Pharmaceuticals

CREST UK: CPX-351 Real-World Effectiveness and Safety Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • Derby, United Kingdom, DE22 3NE
        • University Hospitals Derby and Burton
      • Edinburgh, United Kingdom, EH16 4TJ
        • Western General Hospital (Lothian)
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter
      • Leeds, United Kingdom, LS9 7TF
        • The Leeds Teaching Hospitals Nhs Trust
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, NW1 2BU
        • University College London Hospitals
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital, Portsmouth
      • Torquay, United Kingdom, TQ2 7AA
        • Torbay and South Devon
      • Wirral, United Kingdom, CH63 4JY
        • Royal Liverpool/Clatterbridge
      • Wolverhampton, United Kingdom, WV10 OQP
        • New Cross Hospital - Wolverhampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed, t-AML or AML-MRC who have been treated with Vyxeos liposomal in routine UK clinical practice and managed as per standard local practice will be enrolled in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: CPX-351
This is a retrospective, non-interventional, observational study. No study drug will be administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months
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
Time Frame: First infusion of Vyxeos liposomal (post-August 2018 approval) to date of death, up to approximately 3 years 4 months
First infusion of Vyxeos liposomal (post-August 2018 approval) to date of death, up to approximately 3 years 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months
First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, 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
Time Frame: First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months
First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months
Percentage of Participants Transferred for Haematopoietic Stem Cell Transplant (HSCT) in Participants With AML Who Were Treated in Routine Practice With Vyxeos Liposomal
Time Frame: First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months
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
Time Frame: Date of HSCT to date of death, up to approximately 3 years 4 months
Date of HSCT to date of death, 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
Time Frame: First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months
First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Collaborators

Iqvia Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREST UK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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