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

Mayo Clinic

Status: Enrolling

Conditions: Waldenstrom Macroglobulinemia; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06151730

23-007083 (Other Identifier)

NCI-2023-09519 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Non-Interventional Study