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

Recruiting

• Conditions: Mantle Cell Lymphoma; Marginal Zone Lymphoma; Hematopoietic and Lymphoid System Neoplasm; Chronic Lymphocytic Leukemia; Waldenstrom Macroglobulinemia
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06151730
• Lead Sponsor: Mayo Clinic

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-11-30
• Study Start: 2024-01-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients attend hypertension clinic visits, undergo blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood sample collection and have medical records reviewed throughout study.

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse cardiovascular events (MACE)	Up to 12 months	1-year MACE rates between patients with B-cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies will be compared with patients who do not develop HTN on BTKi.

Secondary Outcome Measures

Name	Time	Method
Incidence of new and/or worsening hypertension (HTN)	Up to 12 months	Incidence of new or worsening HTN over 1 year of BTKi therapy will be recorded (defined as blood pressure (BP) increase to\>140 mmHg systolic or \> 90 mmHg diastolic).
Hemodynamic changes associated with new and/or worsening HTN	Up to 12 months	Impedance cardiography (ICG) changes from before to after BTKi initiation and anti-HTN therapy implication will be recorded to assess hemodynamic changes.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States