A Post-Marketing Observational Study of VYXEOS™

Completed

Conditions studied: Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT03526926

Run by

Jazz Pharmaceuticals

People needed

52

Starts

2018-10-23

Expected to finish

2020-06-12

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Franciscan Physician Network Oncology and Hematology Specialists — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Tulane University Hospital & Clinic — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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