Acute Myeloid Leukemia With Myelodysplasia-Related ChangesNCT03526926
A Post-Marketing Observational Study of VYXEOS™
An observational study of Acute Myeloid Leukemia With Myelodysplasia-Related Changes and Therapy-Related Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
- What is being tested?
- CPX-351
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 7 sitesUnited States
- Study dates
- 23 Oct 2018to 12 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Maryland
Baltimore, Maryland, 21201
Franciscan Physician Network Oncology and Hematology Specialists
Indianapolis, Indiana, 46237
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Washington University School of Medicine
St Louis, Missouri, 63110
University of Kansas Medical Center
Westwood, Kansas, 66205
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Post-Marketing Observational Study of VYXEOS™ to Assess the Incidence of Infusion-Related Reactions in Adult Patients
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
- Being tested
- CPX-351
- Keywords
- newly-diagnosed t-AML or AML-MRC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPX-351Drug
Also called Vyxeos
VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Vyxeos | A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS. Receives: Drug: CPX-351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infusion-Related Reactions on Day 1
The investigator will assess each AE and indicate if it as an infusion-related reaction.
Measured: Day 1
Secondary outcomes (3)
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.
Measured: 1 day after the last infusion
Changes in Vital Signs
Descriptive statistics for observed vital signs will be provided for each infusion
Measured: 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
Measured: 1 day after the last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start23 Oct 2018
- Primary completion26 Oct 2019
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia With Myelodysplasia-Related ChangesStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526926
- Sponsor's protocol ID
- CPX351-402
- Status last verified
- Aug 2020
- First submitted
- 4 May 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Observational Study of VYXEOS™ to Assess the Incidence of Infusion-Related Reactions in Adult Patients
- ClinicalTrials.gov ID
- NCT03526926
- Acronym / sponsor ID
- CPX351-402
- Conditions
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
- Keywords
- newly-diagnosed t-AML or AML-MRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 26 Oct 2019 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vyxeos | – | Drug: CPX-351A minimum of 50 patients who receive at least one infusion of prescribed VYXEOS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPX-351Also: VyxeosVYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes. | Drug | Vyxeos |
Primary outcome
Infusion-Related Reactions on Day 1
Time frame: Day 1
The investigator will assess each AE and indicate if it as an infusion-related reaction.
3 secondary outcomes
Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion
Time frame: 1 day after the last infusion
Changes in Vital Signs
Time frame: Up to 180 minutes after the start of infusion
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: 1 day after the last infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia With Myelodysplasia-Related Changes and Therapy-Related Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infusion-Related Reactions on Day 1 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.