CompletedNot Applicable

A Post-Marketing Observational Study of VYXEOS™

United States52 participantsStarted 2018-10-23

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Infusion-Related Reactions on Day 1

Timeframe: Day 1

Trial details

NCT IDNCT03526926

SponsorJazz Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-10-26

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