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Trial Title:
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
NCT ID:
NCT06151730
Condition:
Chronic Lymphocytic Leukemia
Hematopoietic and Lymphoid System Neoplasm
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Conditions: Official terms:
Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Waldenstrom Macroglobulinemia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
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 blood pressure monitoring,
electrocardiograms, impedance cardiography testing and blood sample collection and have
medical records reviewed throughout study.
Criteria for eligibility:
Study pop:
Patients with B-cell malignancies on BTKi treatment at Mayo Clinic.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL),
Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL) to begin Bruton
tyrosine kinase inhibitors (BTKi) treatment (either as a single agent or on
combination with others), 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Joerg Herrmann, M.D.
Email:
Principal Investigator
Start date:
January 5, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151730
https://www.mayo.edu/research/clinical-trials
