Clinical trial · Observational
A Post-Marketing Observational Study of VYXEOS™
A Post-Marketing Observational Study of VYXEOS™ to Assess the Incidence of Infusion-Related Reactions in Adult Patients
NCT03526926CI-TRIAL-00046456completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia With Myelodysplasia-Related Changes | Acute Myeloid Leukemia, Myelodysplasia-Related | ALIAS | 0.90 |
| Therapy-Related Acute Myeloid Leukemia | Acute Myeloid Leukemia Post Cytotoxic Therapy | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPX-351 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Vyxeos
- description
- A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.
- interventionNames
- Drug: CPX-351
Primary outcomes (1)
- measure
- Infusion-Related Reactions on Day 1
- timeFrame
- Day 1
- description
- The investigator will assess each AE and indicate if it as an infusion-related reaction.
Secondary outcomes (3)
- measure
- Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion
- timeFrame
- 1 day after the last infusion
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.