Recruiting

Bruton Tyrosine Kinase InhibitorsEvaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study

Sponsor:

Mayo Clinic

Code:

NCT06151730

Conditions

Chronic Lymphocytic Leukemia

Hematopoietic and Lymphoid System Neoplasm

Mantle Cell Lymphoma

Marginal Zone Lymphoma

Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.

Conditions

Chronic Lymphocytic Leukemia

Hematopoietic and Lymphoid System Neoplasm

Mantle Cell Lymphoma

Marginal Zone Lymphoma

Waldenstrom Macroglobulinemia

Study ID

NCT06151730

Start date

Jan 5, 2024

Status verified date

Feb, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL), planned to begin Bruton tyrosine kinase inhibitors (BTKi) treatment or who will start a new BTKi agent after a 5-day wash out period (either as a single agent or on combination with other chemotherapies), who are willing to return to Mayo Clinic for ongoing follow-up

Exclusion Criteria:

Patients with known central nervous system (CNS) involvement of their B-cell malignancy

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients attend hypertension clinic visits, undergo optional blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood and urine sample collection and have medical records reviewed throughout study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

Incidence of major adverse cardiovascular events (MACE) [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Joerg Herrmann, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-27.