Leukemia, Myeloid, AcuteNCT03760237
Cardiovascular Function in Acute Leukemia
An observational study of Leukemia, Myeloid, Acute and Leukemia, Lymphoid, Acute, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Acute, Cardiotoxicity
- What is being tested?
- observation only
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 6 May 2024
- How long will I take part?
- 1 Year
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are newly diagnosed with acute leukemia
Who may be able to join
- Older than 18 years of age,
- New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included).
- Signed the informed consent form
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Cardiovascular Function in Leukemia Patients: an Observational Prospective Study
An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.
Read the detailed description
Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.
- Being tested
- observation only
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation onlyOther
No intervention, observational study only
| Study group | Role | What they receive |
|---|---|---|
| Acute Leukemia | Observation only. Patients newly diagnosed with acute leukemia who are scheduled to start treatment with chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year. Receives: Other: observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular dysfunction
defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%.
Measured: 1 year
Secondary outcomes (3)
Incidence of Cardiovascular Events
Measured: 1 year
Incidence of Symptomatic Heart Failure
Measured: 1 year
Incidence of Cardiac Death and all mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start10 Dec 2018
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 84 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marielle Scherrer-Crosbie, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760237
- Sponsor's protocol ID
- UPCC48418
- Status last verified
- May 2024
- First submitted
- 29 Nov 2018
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Function in Leukemia Patients: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03760237
- Acronym / sponsor ID
- UPCC48418
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 30 Nov 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.
An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.
Detailed description
Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Leukemia | – | Other: observation onlyObservation only. Patients newly diagnosed with acute leukemia who are scheduled to start treatment with chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are newly diagnosed with acute leukemia
Key inclusion criteria (3 listed)
- Older than 18 years of age,
- New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included).
- Signed the informed consent form
Key exclusion criteria (1 listed)
- Unable to provide informed consent
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 |
|---|---|---|
| observation onlyNo intervention, observational study only | Other | Acute Leukemia |
Primary outcome
Left Ventricular dysfunction
Time frame: 1 year
defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%.
3 secondary outcomes
Incidence of Cardiovascular Events
Time frame: 1 year
Incidence of Symptomatic Heart Failure
Time frame: 1 year
Incidence of Cardiac Death and all mortality
Time frame: 1 year
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 10 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Marielle Scherrer-Crosbie, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Acute and Leukemia, Lymphoid, Acute, run by Abramson Cancer Center at Penn Medicine at 1 site 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 3 inclusion and 1 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Left Ventricular dysfunction (time frame: 1 year). 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 10 Oct 2024.