A Post-Marketing Observational Study of VYXEOS™

Therapy-Related Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526926
• Other study ID #: CPX351-402
• Status: Completed
• Start date: October 23, 2018
• Est. completion date: June 12, 2020

Study information

• Verified date: August 2020
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 12, 2020
• Est. primary completion date: October 26, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia With Myelodysplasia-Related Changes
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Therapy-Related Acute Myeloid Leukemia

Intervention

Drug:
• CPX-351
VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infusion-Related Reactions on Day 1	The investigator will assess each AE and indicate if it as an infusion-related reaction.	Day 1
Secondary	Incidence of Infusion-Related Reactions Occurring until One 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.	1 day after the last infusion
Secondary	Changes in Vital Signs	Descriptive statistics for observed vital signs will be provided for each infusion	Up to 180 minutes after the start of infusion
Secondary	Incidence of Treatment-emergent Adverse Events (TEAEs)	Treatment-emergent adverse events (TEAEs) are defined as any AE starting after the initiation of the first infusion of VYXEOS	1 day after the last infusion