A Post-Marketing Observational Study of VYXEOS™

Status:	Recruiting
Conditions:	Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/17/2019
Start Date:	October 23, 2018
End Date:	January 2020
Contact:	Director Clinical Trial Disclosure & Transparency
Email:	ClinicalTrialDisclosure@JazzPharma.com
Phone:	(215) 832-3750

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

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.

Inclusion Criteria:

1. 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.

2. Ability to understand and voluntarily give informed consent and understand the
requirements of the registry.

3. Age ≥ 18 years.

4. Initiating VYXEOS therapy for the first time according to the current prescribing
information.

5. Initiating VYXEOS therapy for the first time according to standard institutional
practice.

Exclusion Criteria:

1. Prior treatment with VYXEOS.

2. 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.

We found this trial at

sites

University of Maryland

Baltimore, Maryland 20742

(301) 405-1000