A Post-Marketing Observational Study of VYXEOS™

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: CPX-351


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vyxeos<br>A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS. | Drug: CPX-351<br>* VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.<br>* Other names: Vyxeos;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newly-diagnosed t-AML or AML-MRC