A Post-Marketing Observational Study of VYXEOS™
1 other identifier
observational
52
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedStudy Start
First participant enrolled
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2020
CompletedAugust 5, 2020
August 1, 2020
1 year
May 4, 2018
August 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infusion-Related Reactions on Day 1
The investigator will assess each AE and indicate if it as an infusion-related reaction.
Day 1
Secondary Outcomes (3)
Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion
1 day after the last infusion
Changes in Vital Signs
Up to 180 minutes after the start of infusion
Incidence of Treatment-emergent Adverse Events (TEAEs)
1 day after the last infusion
Study Arms (1)
Vyxeos
A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.
Interventions
VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.
Eligibility Criteria
A minimum of 50 patients who have received at least one infusion of prescribed VYXEOS at a dose of 44 mg/m2 daunorubicin and 100 mg/m2 cytarabine are planned for this study.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Franciscan Physician Network Oncology and Hematology Specialists
Indianapolis, Indiana, 46237, United States
University of Kansas Medical Center
Westwood, Kansas, 66205, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Interventions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
May 16, 2018
Study Start
October 23, 2018
Primary Completion
October 26, 2019
Study Completion
June 12, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08