Clinical trial · Observational
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
Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-Cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors (HALT) - A Pilot Study
NCT06151730CI-TRIAL-00104104recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Incidence of major adverse cardiovascular events (MACE)
- timeFrame
- Up to 12 months
- description
- 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 outcomes (2)
- measure
- Incidence of new and/or worsening hypertension (HTN)
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.