Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
Conditions
Keywords
newly-diagnosed t-AML or AML-MRC
Brief summary
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.
Interventions
DRUGCPX-351
VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.
Sponsors
Jazz Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infusion-Related Reactions on Day 1 | Day 1 | The investigator will assess each AE and indicate if it as an infusion-related reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion | 1 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. |
| Changes in Vital Signs | Up to 180 minutes after the start of infusion | Descriptive statistics for observed vital signs will be provided for each infusion |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | 1 day after the last infusion | Treatment-emergent adverse events (TEAEs) are defined as any AE starting after the initiation of the first infusion of VYXEOS |
Countries
United States
Outcome results
None listed