A Post-Marketing Observational Study of VYXEOS™

Jazz Pharmaceuticals

Status: Completed

Conditions: Therapy-Related Acute Myeloid Leukemia; Acute Myeloid Leukemia With Myelodysplasia-Related Changes

Treatments: Drug: CPX-351

Study type: Observational

Funder types: Industry

Identifiers

NCT03526926

CPX351-402

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

52 participants in 1 patient group

Vyxeos

Description:

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

Treatment:

Drug: CPX-351