A Post-Marketing Observational Study of VYXEOS™

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-23

Study Completion Date

2020-06-12

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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vyxeos

A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.

CPX-351

Intervention Type DRUG

VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.

Interventions

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CPX-351

VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.

Intervention Type DRUG

Other Intervention Names

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Vyxeos

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No