CPX-351 Real-World Effectiveness and Safety Study

NCT05169307 | Completed

• 1 other identifier: CREST UK
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 15

Brief Summary

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

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; CPX-351; Vyxeos liposomal

Outcome Measures

Primary Outcomes (2)

• 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

  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

  First infusion of Vyxeos liposomal (post-August 2018 approval) to date of death, up to approximately 3 years 4 months

Secondary Outcomes (5)

• 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

  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

  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

  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

  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

  First infusion of Vyxeos liposomal (post-August 2018 approval) to inclusion in study, up to approximately 3 years 4 months

Study Arms (1)

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

Interventions

CPX-351 DRUG

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

CPX-351

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Iqvia Pty Ltd: collaborator

Study Sites (15)

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

University Hospitals Derby and Burton

Derby, DE22 3NE, United Kingdom

Location

Western General Hospital (Lothian)

Edinburgh, EH16 4TJ, United Kingdom

Location

Royal Devon and Exeter

Exeter, EX2 5DW, United Kingdom

Location

The Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

University College London Hospitals

London, NW1 2BU, United Kingdom

Location

Royal Marsden

London, SW3 6JJ, United Kingdom

Location

Royal Liverpool/Clatterbridge

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Peterborough Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

Queen Alexandra Hospital, Portsmouth

Portsmouth, PO6 3LY, United Kingdom

Location

Torbay and South Devon

Torquay, TQ2 7AA, United Kingdom

Location

New Cross Hospital - Wolverhampton

Wolverhampton, WV10 OQP, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

CPX-351

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 23, 2021
• Study Start: January 14, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (15)