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Completed

NCT Number: NCT03526926

A Post-Marketing Observational Study of VYXEOS™

The purpose of this observational study is to provide data on the incidence and severity of infusion-related reactions during and immediately following each infusion of VYXEOS during the first induction.

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Key information

Conditions

Acute Myeloid Leukemia With Myelodysplasia-Related Changes Therapy-Related Acute Myeloid Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Franciscan Physician Network Oncology and Hematology Specialists, Indianapolis, Indiana, United States

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Who can participate

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

Inclusion criteria

  • The decision to prescribe VYXEOS must have been made prior to enrollment in this study and based upon approved US indications and dosing: 44mg/m2 daunorubicin and cytarabine 100 mg/2 on Days 1, 3, and 5.
  • Ability to understand and voluntarily give informed consent and understand the requirements of the registry.
  • Age ≥ 18 years.
  • Initiating VYXEOS therapy for the first time according to the current prescribing information.
  • Initiating VYXEOS therapy for the first time according to standard institutional practice.

Exclusion criteria

  • Prior treatment with VYXEOS.
  • Patients receiving any investigational agent other than VYXEOS (e.g., any drug or biologic agent or medical device that has not received approval in the US) or receiving VYXEOS for any indication not currently approved in the US.

Treatment and study plan

CPX-351

Drug

VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.

Other names: Vyxeos

Primary outcomes

  1. Infusion-Related Reactions on Day 1

    Time frame: Day 1

    The investigator will assess each AE and indicate if it as an infusion-related reaction.

Secondary outcomes

  1. Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion

    Time frame: 1 day after the last infusion

    The number and percentage of patients assessed by the investigator to have had any AEs assessed to be an infusion-related reaction occurring until 1 day after the last infusion.

  2. Changes in Vital Signs

    Time frame: Up to 180 minutes after the start of infusion

    Descriptive statistics for observed vital signs will be provided for each infusion

  3. Incidence of Treatment-emergent Adverse Events (TEAEs)

    Time frame: 1 day after the last infusion

    Treatment-emergent adverse events (TEAEs) are defined as any AE starting after the initiation of the first infusion of VYXEOS

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

A Post-Marketing Observational Study of VYXEOS™ to Assess the Incidence of Infusion-Related Reactions in Adult Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 16, 2018
Registry last updated
Aug 5, 2020

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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