A Post-Marketing Observational Study of VYXEOS™
Purpose
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.
Conditions
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes
- Therapy-Related Acute Myeloid Leukemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. 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
- 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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Vyxeos | A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS. |
|
More Details
- Status
- Completed
- Sponsor
- Jazz Pharmaceuticals