Chronic Lymphocytic LeukemiaNCT05521178
Cardiotoxicities in Patients Receiving BTKi
An observational study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Dana-Farber Cancer Institute.
Trial summary
This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Electrocardiogram, Echocardiogram and Cardiac magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2024to 1 Jan 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed diagnosis of CLL who are planned to start either ibrutinib or acalabrutinib per standard of care, in monotherapy or in combination with an anti-CD20 antibody, venetoclax, and/or a PI3K inhibitor. Both treatment-naïve and relapsed or refractory CLL are allowed.
Who may be able to join
- Patients with confirmed diagnosis of CLL who are planned to start either ibrutinib or acalabrutinib per standard of care, in monotherapy or in combination with an anti-CD20 antibody, venetoclax, and/or a PI3K inhibitor. Both treatment-naïve and relapsed or refractory CLL are allowed.
- No known history of paroxysmal, persistent, or permanent atrial fibrillation. Exception: The study allows enrollment of up to 10 patients with a known history of paroxysmal atrial fibrillation (exploratory cohort).
- No known history chronic symptomatic congestive heart failure or documented ejection fraction < 50%.
- Creatinine ≤ 1.5x institutional upper limit of normal (ULN). An adequate kidney function is necessary to ensure safety of IV contrast given before cardiac MRI.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
Who cannot join
- Prior exposure to ibrutinib or acalabrutinib.
- Patients with a clinical contraindication to MRI.
- Patients with childbearing potential who cannot or do not wish to use an effective method of contraception, during the study period and for 12 months after the final treatment used for the purposes of the study.
- Patients with any medical condition, psychiatric condition, or social situation that in the opinion of the investigator would compromise compliance with study requirements.
About this study
Official title: A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL
This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.
Read the detailed description
This research study includes three visits for research blood, physical exam, and cardiac testing at baseline, 3 months, and 6 months. The study will collect the following data during the 6-month study period:
- Blood sample collection
- Electrocardiogram (ECG)
- Echocardiogram
- Cardiac magnetic resonance imaging (MRI)
- Mobile cardiac telemetry
- Blood pressure measurement
- Being tested
- Electrocardiogram, Echocardiogram, Cardiac magnetic resonance imaging, Mobile cardiac telemetry, Blood pressure monitoring
- Keywords
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDiagnostic test
Also called ECG
ECG to monitor electrical activities of the heart on each visit
EchocardiogramDiagnostic test
Also called TTE
Echocardiogram at baseline and 6 months
Cardiac magnetic resonance imagingDiagnostic test
Also called Cardiac MRI
Cardiac MRI at baseline and 6 months
Mobile cardiac telemetryDevice
Also called Mobile telemetry
Mobile cardiac telemetry at baseline and 6 months
Blood pressure monitoringDiagnostic test
Also called Home blood pressure monitoring
Home blood pressure monitoring three times per week
Blood drawDiagnostic test
Blood draw at baseline, 3 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib | Patients receiving ibrutinib for the treatment of CLL. Receives: Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac magnetic resonance imaging; Device: Mobile cardiac telemetry; Diagnostic Test: Blood pressure monitoring; Diagnostic Test: Blood draw | |
| Acalabrutinib | Patients receiving acalabrutinib for the treatment of CLL. Receives: Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac magnetic resonance imaging; Device: Mobile cardiac telemetry; Diagnostic Test: Blood pressure monitoring; Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial arrhythmias
Any documented evidence of atrial arrhythmia including symptomatic and asymptomatic events captured by EKG, 28-day mini cardiac telemetry, or monitoring of cardiac rhythm during echocardiogram or cardiac MRI.
Measured: During 6 months of BTK inhibitor therapy
Secondary outcomes (2)
Incidence of ventricular arrhythmias
Assessed by 28-day mobile telemetry
Measured: During 6 months of BTK inhibitor therapy
Severity of ventricular arrythmia
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: During 6 months of BTK inhibitor therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study startMay 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Why it stopped: Funding for study was withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Inhye Ahn, Dana-Farber Cancer Institute
- Investigators
- Inhye Ahn, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521178
- Sponsor's protocol ID
- 22-301
- Status last verified
- Oct 2024
- First submitted
- 28 Aug 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL
- ClinicalTrials.gov ID
- NCT05521178
- Acronym / sponsor ID
- 22-301
- Keywords
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding for study was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- May 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 30 Aug 2022 (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 is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.
Detailed description
This research study includes three visits for research blood, physical exam, and cardiac testing at baseline, 3 months, and 6 months. The study will collect the following data during the 6-month study period:
- Blood sample collection
- Electrocardiogram (ECG)
- Echocardiogram
- Cardiac magnetic resonance imaging (MRI)
- Mobile cardiac telemetry
- Blood pressure measurement
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib | – | Diagnostic Test: Electrocardiogram, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac magnetic resonance imaging, Device: Mobile cardiac telemetry, Diagnostic Test: Blood pressure monitoring, Diagnostic Test: Blood drawPatients receiving ibrutinib for the treatment of CLL. |
| Acalabrutinib | – | Diagnostic Test: Electrocardiogram, Diagnostic Test: Echocardiogram, Diagnostic Test: Cardiac magnetic resonance imaging, Device: Mobile cardiac telemetry, Diagnostic Test: Blood pressure monitoring, Diagnostic Test: Blood drawPatients receiving acalabrutinib for the treatment of CLL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed diagnosis of CLL who are planned to start either ibrutinib or acalabrutinib per standard of care, in monotherapy or in combination with an anti-CD20 antibody, venetoclax, and/or a PI3K inhibitor. Both treatment-naïve and relapsed or refractory CLL are allowed.
Key inclusion criteria (6 listed)
- Patients with confirmed diagnosis of CLL who are planned to start either ibrutinib or acalabrutinib per standard of care, in monotherapy or in combination with an anti-CD20 antibody, venetoclax, and/or a PI3K inhibitor. Both treatment-naïve and relapsed or refractory CLL are allowed.
- No known history of paroxysmal, persistent, or permanent atrial fibrillation. Exception: The study allows enrollment of up to 10 patients with a known history of paroxysmal atrial fibrillation (exploratory cohort).
- No known history chronic symptomatic congestive heart failure or documented ejection fraction < 50%.
- Creatinine ≤ 1.5x institutional upper limit of normal (ULN). An adequate kidney function is necessary to ensure safety of IV contrast given before cardiac MRI.
- Age ≥18 years.
Key exclusion criteria (4 listed)
- Prior exposure to ibrutinib or acalabrutinib.
- Patients with a clinical contraindication to MRI.
- Patients with childbearing potential who cannot or do not wish to use an effective method of contraception, during the study period and for 12 months after the final treatment used for the purposes of the study.
- Patients with any medical condition, psychiatric condition, or social situation that in the opinion of the investigator would compromise compliance with study requirements.
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 |
|---|---|---|
| ElectrocardiogramAlso: ECGECG to monitor electrical activities of the heart on each visit | Diagnostic test | Acalabrutinib, Ibrutinib |
| EchocardiogramAlso: TTEEchocardiogram at baseline and 6 months | Diagnostic test | Acalabrutinib, Ibrutinib |
| Cardiac magnetic resonance imagingAlso: Cardiac MRICardiac MRI at baseline and 6 months | Diagnostic test | Acalabrutinib, Ibrutinib |
| Mobile cardiac telemetryAlso: Mobile telemetryMobile cardiac telemetry at baseline and 6 months | Device | Acalabrutinib, Ibrutinib |
| Blood pressure monitoringAlso: Home blood pressure monitoringHome blood pressure monitoring three times per week | Diagnostic test | Acalabrutinib, Ibrutinib |
| Blood drawBlood draw at baseline, 3 and 6 months | Diagnostic test | Acalabrutinib, Ibrutinib |
Primary outcome
Incidence of atrial arrhythmias
Time frame: During 6 months of BTK inhibitor therapy
Any documented evidence of atrial arrhythmia including symptomatic and asymptomatic events captured by EKG, 28-day mini cardiac telemetry, or monitoring of cardiac rhythm during echocardiogram or cardiac MRI.
2 secondary outcomes
Incidence of ventricular arrhythmias
Time frame: During 6 months of BTK inhibitor therapy
Severity of ventricular arrythmia
Time frame: During 6 months of BTK inhibitor therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Inhye Ahn, MD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Dana-Farber Cancer Institute.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of atrial arrhythmias (time frame: During 6 months of BTK inhibitor therapy). 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 15 Oct 2024.