Evaluating blood pressure management in patients with B-cell cancers on specific treatments
Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-Cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors (HALT) - A Pilot Study
This study is trying to see how blood pressure changes in people with B-cell cancers who are being treated with a specific type of medication, and what the best ways are to manage any high blood pressure they might develop.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06151730 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of new and worsening hypertension in patients with B-cell malignancies undergoing treatment with Bruton Tyrosine Kinase Inhibitors (BTKis). It will identify hemodynamic changes associated with hypertension using impedance cardiography and determine optimal antihypertensive strategies. Additionally, the study will compare major adverse cardiovascular event (MACE) rates between patients experiencing hypertension and those who do not while on BTKis. Participants will attend hypertension clinic visits and undergo various monitoring and testing procedures throughout the study.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with chronic lymphocytic leukemia, mantle cell lymphoma, Waldenstrom macroglobulinemia, or marginal zone lymphoma who are starting treatment with BTKis.
Not a fit: Patients with known central nervous system involvement of their B-cell malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hypertension in patients with B-cell malignancies, potentially reducing cardiovascular risks.
How similar studies have performed: While this approach is novel in the context of BTKis and hypertension management, similar studies have shown the importance of monitoring cardiovascular health in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Joerg Herrmann, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.