A Post-Marketing Observational Study of VYXEOS™

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.

Study Overview

• Status: Completed
• Conditions: Therapy-Related Acute Myeloid Leukemia; Acute Myeloid Leukemia With Myelodysplasia-Related Changes
• Intervention / Treatment: Drug: CPX-351

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Physician Network Oncology and Hematology Specialists
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University Of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital & Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infusion-Related Reactions on Day 1	The investigator will assess each AE and indicate if it as an infusion-related reaction.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Actual): October 26, 2019
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: newly-diagnosed t-AML or AML-MRC
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia
• Other Study ID Numbers: CPX351-402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes