What side effects are associated with this type of intervention?

The most common treatments for Chronic Lymphocytic Leukemia (CLL) using Bruton Tyrosine Kinase (BTK) inhibitors, such as ibrutinib, acalabrutinib, and zanubrutinib, are associated with several side effects. These include partial alopecia, hair curling, and dyspigmentation. Additionally, patients may experience cardiotoxicity, with ibrutinib having a higher incidence of atrial fibrillation and hypertension. Other common side effects include infections, bleeding complications, and gastrointestinal issues. Acalabrutinib and zanubrutinib are generally better tolerated than ibrutinib, with fewer nonhematologic adverse effects.

What prior FDA approvals exist?

The FDA has approved several Bruton Tyrosine Kinase (BTK) inhibitors for the treatment of Chronic Lymphocytic Leukemia (CLL). These include ibrutinib, acalabrutinib, and zanubrutinib. Ibrutinib was one of the first BTK inhibitors approved and has extensive long-term data supporting its efficacy and safety. Acalabrutinib and zanubrutinib are newer BTK inhibitors that have shown similar efficacy with potentially better tolerability profiles compared to ibrutinib. These drugs work by inhibiting BTK to disrupt B-cell receptor signaling, which is crucial for the survival and proliferation of CLL cells.

What other types of research exist?

Promising alternatives to BTK inhibitors for CLL patients include venetoclax plus obinutuzumab. This combination has demonstrated higher overall response rates, more complete responses, and superior progression-free survival compared to traditional therapies. Venetoclax plus obinutuzumab is particularly useful for patients with comorbidities or those who are poor candidates for BTK inhibitors.

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Device

Implanted Loop Recorder for Arrhythmia Detection

N/A

Recruiting

Led By Robert S Copeland-Halperin, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>18 years old

Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)

Must not have

Patient is taking an anti-arrhythmic or anticoagulant

Heart surgery within past 90 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 months after start of btk inhibitor

Awards & highlights

No Placebo-Only Group

Summary

This trial uses BTK inhibitors and a small heart monitor device to track new heart rhythm issues in patients starting these medications who have no prior history of such problems. The drugs help stop cancer cell growth, while the monitor continuously records heart activity. Ibrutinib and other novel BTK inhibitors have been developed and tested for the treatment of B-cell malignancies and autoimmune disorders.

Who is the study for?

Adults over 18 starting Bruton Tyrosine Kinase inhibitors for conditions like CLL, who agree to heart monitoring and haven't had arrhythmias or strokes in the past year. Excludes those with recent heart surgery, myocardial infarction, other implants, or on anti-arrhythmic/anticoagulant drugs.

What is being tested?

The trial is testing if a Medtronic LINQ-2 Insertable Cardiac Monitor can detect new atrial fibrillation or other arrhythmias in patients beginning BTK inhibitor treatment without prior documented arrhythmia.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, infection risk from the procedure, and possible allergic reactions to device materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am starting a BTK inhibitor treatment for my condition.

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I agree to have a heart monitor inserted before starting BTK inhibitor treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for irregular heartbeat or blood thinning.

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I have not had heart surgery in the last 90 days.

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I have not had a stroke or mini-stroke in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 months after start of btk inhibitor

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 18 months after start of btk inhibitor

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 months after start of btk inhibitor for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of device detected atrial fibrillation (AF)

Long term Incidence of device detected AF

Secondary study objectives

BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.

Incidence of device detected ventricular arrhythmia (VA)

Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILRExperimental Treatment1 Intervention

Patients free of documented arrhythmia initiating treatment with a BTK inhibitor who consent to monitoring using the Medtronic LINQ-2 implanted cardiac monitoring device (ILR) prior to initiating BTK inhibitor therapy.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bruton Tyrosine Kinase (BTK) inhibitors, such as ibrutinib, acalabrutinib, and zanubrutinib, are common treatments for Chronic Lymphocytic Leukemia (CLL). These drugs work by inhibiting the BTK enzyme, which is essential for B-cell receptor signaling. By disrupting this pathway, BTK inhibitors prevent the survival and proliferation of malignant B-cells, which are characteristic of CLL. This targeted approach is significant for CLL patients as it offers a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.