A Post-Marketing Observational Study of VYXEOS™ | NCT03526926

Studies
A Post-Marketing Observational Study of VYXEOS™

NCT03526926

Sponsor

Jazz Pharmaceuticals

Status

Completed

Last Update Posted

Aug 5, 2020Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Therapy-Related Acute Myeloid Leukemia

Interventions

CPX-351

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2018Actual

Primary Completion Date

Oct 26, 2019Actual

Completion Date

Jun 12, 2020Actual

First Submitted Date

May 4, 2018

First Submission Date that Met QC Criteria

May 4, 2018

First Posted Date

May 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vyxeos		A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS.	Drug: CPX-351

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPX-351	Drug	VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.	Vyxeos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infusion-Related Reactions on Day 1	The investigator will assess each AE and indicate if it as an infusion-related reaction.	Day 1

Secondary Outcomes

Measure	Description	Time Frame
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.	1 day after the last infusion
Changes in Vital Signs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.
Ability to understand and voluntarily give informed consent and understand the requirements of the registry.
Age ≥ 18 years.
Initiating VYXEOS therapy for the first time according to the current prescribing information.
Initiating VYXEOS therapy for the first time according to standard institutional practice.

Exclusion Criteria:

Prior treatment with VYXEOS.
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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Franciscan Physician Network Oncology and Hematology Specialists		Indianapolis	Indiana	46237	United States