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NCT Number: NCT05169307

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Belfast City Hospital, Belfast, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPX-351

Drug

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2021
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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