CPX-351 Real-World Effectiveness and Safety Study

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05169307
• Other study ID #: CREST UK
• Status: Completed
• Start date: January 14, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: July 2022
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CPX-351
This is a retrospective, non-interventional, observational study. No study drug will be administered in this study.

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	University Hospitals Derby and Burton	Derby
United Kingdom	Western General Hospital (Lothian)	Edinburgh
United Kingdom	Royal Devon and Exeter	Exeter
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Royal Marsden	London
United Kingdom	University College London Hospitals	London
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Peterborough Hospital	Peterborough
United Kingdom	Queen Alexandra Hospital, Portsmouth	Portsmouth
United Kingdom	Torbay and South Devon	Torquay
United Kingdom	Royal Liverpool/Clatterbridge	Wirral
United Kingdom	New Cross Hospital - Wolverhampton	Wolverhampton

Sponsors (2)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals	Iqvia Pty Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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