Cardiovascular DiseasesCARTCONCT05130489
CAR T Cell Therapy Related Cardiovascular Outcomes
An observational study of Cardiovascular Diseases and B-cell Acute Lymphoblastic Leukemia, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiovascular Diseases, B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma Refractory
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2021to 1 May 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving CD19-specific CAR T cell therapy for the management of relapsing or refractory haematological malignancy at the MacMillan Cancer Centre within the University College London Hospital will be considered for participation.
Who may be able to join
- Patients with capacity, (aged 16 and older)
- Undergoing CAR T cells for treatment for relapsing or refractory haematological malignancies
Who cannot join
- Patients under 16 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes
This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.
Read the detailed description
CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood.
This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up.
The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.
- Conditions
- Cardiovascular Diseases, B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma Refractory, B-cell Lymphoma Recurrent, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Diffuse Large B Cell Lymphoma
- Keywords
- Cardio-oncology, CAR T cell therapy, Cardiotoxicity
- Medical subject headings
- Cardiovascular Diseases, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Detected abnormalities - Composite
The primary outcome is a composite of detected abnormalities on biomarkers, transthoracic echocardiogram (TTE), or Cardiac magnetic resonance (CMR) following CAR T cell infusion.
Measured: 3 months
Secondary outcomes (1)
Detected abnormalities - Individual
The secondary outcome measures includes a composite of detected abnormalities of factors on cardiac biomarkers (troponin and N-terminal pro B-type natriuretic peptide) , electrocardiogram (ECG) changes and acute heart failure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start18 Jan 2021
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Yellon, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130489
- Sponsor's protocol ID
- 20/SC/0301
- Acronym
- CARTCO
- Status last verified
- May 2023
- First submitted
- 4 Nov 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes
- ClinicalTrials.gov ID
- NCT05130489
- Acronym / sponsor ID
- CARTCO / 20/SC/0301
- Conditions
- Cardiovascular Diseases, B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma Refractory, B-cell Lymphoma Recurrent, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Diffuse Large B Cell Lymphoma
- Keywords
- Cardio-oncology, CAR T cell therapy, Cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 23 Nov 2021 (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.
This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.
Detailed description
CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood.
This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up.
The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving CD19-specific CAR T cell therapy for the management of relapsing or refractory haematological malignancy at the MacMillan Cancer Centre within the University College London Hospital will be considered for participation.
Key inclusion criteria (2 listed)
- Patients with capacity, (aged 16 and older)
- Undergoing CAR T cells for treatment for relapsing or refractory haematological malignancies
Key exclusion criteria (1 listed)
- Patients under 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detected abnormalities - Composite
Time frame: 3 months
The primary outcome is a composite of detected abnormalities on biomarkers, transthoracic echocardiogram (TTE), or Cardiac magnetic resonance (CMR) following CAR T cell infusion.
1 secondary outcome
Detected abnormalities - Individual
Time frame: 3 months
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 12 May 2023.
- Individual participant dataSharing planned: No
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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.
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 Cardiovascular Diseases and B-cell Acute Lymphoblastic Leukemia, run by University College London Hospitals at 1 site in United Kingdom.
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 2 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 12 May 2023. 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 Kingdom. 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?
Detected abnormalities - Composite (time frame: 3 months). 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 12 May 2023.