A Post-Marketing Observational Study of VYXEOS™

Completed

• Conditions: Acute Myeloid Leukemia With Myelodysplasia-Related Changes; Therapy-Related Acute Myeloid Leukemia
• Interventions: Drug: CPX-351

• Registration Number: NCT03526926
• Lead Sponsor: Jazz Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-16
• Study Start: 2018-10-23
• Primary Completion: 2019-10-26
• Study Completion: 2020-06-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vyxeos	CPX-351	A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (7)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Tulane University Hospital & Clinic; 🇺🇸 New Orleans, Louisiana, United States

Franciscan Physician Network Oncology and Hematology Specialists; 🇺🇸 Indianapolis, Indiana, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Westwood, Kansas, United States