An observational study in Acute Myeloid Leukemia With Myelodysplasia-Related Changes and Therapy-Related Acute Myeloid Leukemia, sponsored by Jazz Pharmaceuticals. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Jazz Pharmaceuticals · Observational
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 52 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
A minimum of 50 patients who have received at least one infusion of prescribed VYXEOS at a dose of 44 mg/m2 daunorubicin and 100 mg/m2 cytarabine are planned for this study.
Exclusion Criteria:
A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.
Drug: CPX-351
VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.
Also known as: Vyxeos
Infusion-Related Reactions on Day 1
The investigator will assess each AE and indicate if it as an infusion-related reaction.
Time frame: Day 1
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.
Time frame: 1 day after the last infusion
Changes in Vital Signs
Descriptive statistics for observed vital signs will be provided for each infusion
Time frame: 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
Time frame: 1 day after the last infusion
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Jazz Pharmaceuticals