A Post-Marketing Observational Study of VYXEOS™

Sponsor

Jazz Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03526926

Collaborator

(none)

Enrollment

Locations

19.6

Actual Duration (Months)

7.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia With Myelodysplasia-Related Changes Therapy-Related Acute Myeloid Leukemia	Drug: CPX-351

Study Design

Study Type:

Observational

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 23, 2018

Actual Primary Completion Date :

Oct 26, 2019

Actual Study Completion Date :

Jun 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Vyxeos A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.	Drug: CPX-351 VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes. Other Names: Vyxeos

Arm

Intervention/Treatment

Vyxeos

A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.

Drug: CPX-351

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

Other Names:

Vyxeos

Outcome Measures

Primary Outcome Measures

Infusion-Related Reactions on Day 1 [Day 1]
The investigator will assess each AE and indicate if it as an infusion-related reaction.

Secondary Outcome Measures

Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion [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.
Changes in Vital Signs [Up to 180 minutes after the start of infusion]
Descriptive statistics for observed vital signs will be provided for each infusion
Incidence of Treatment-emergent Adverse Events (TEAEs) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Franciscan Physician Network Oncology and Hematology Specialists	Indianapolis	Indiana	United States	46237
2	University of Kansas Medical Center	Westwood	Kansas	United States	66205
3	Tulane University Hospital & Clinic	New Orleans	Louisiana	United States	70112
4	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
5	University of Maryland	Baltimore	Maryland	United States	21201
6	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
7	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27157