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

Last updated: March 13, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Platelet Disorders

Lymphoproliferative Disorders

Chronic Lymphocytic Leukemia

Treatment

Non-Interventional Study

Clinical Study ID

NCT06151730
23-007083
23-007083
NCI-2023-09519
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with known central nervous system (CNS) involvement of their B-cellmalignancy

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Non-Interventional Study
Phase:
Study Start date:
January 05, 2024
Estimated Completion Date:
December 01, 2025

Study Description

PRIMARY OBJECTIVES:

I. To prospectively define the incidence of new and/or worsening HTN in patients with B-cell malignancies on BTKi.

II. To identify the hemodynamic changes associated with new and/or worsening HTN in patients with B-cell malignancies on BTKi by impedance cardiography (ICG) and thereby to define the optimal anti-hypertensive strategies.

III. To compare 1-year MACE rates between patients with B cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies with patients who do not develop HTN on BTKis.

OUTLINE: This is an observational study.

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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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