Chronic Lymphocytic LeukemiaNCT06151730
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
An observational study of Chronic Lymphocytic Leukemia and Hematopoietic and Lymphoid System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Mantle Cell Lymphoma
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with B-cell malignancies on BTKi treatment at Mayo Clinic.
Who may be able to join
- 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
Who cannot join
- Patients with known central nervous system (CNS) involvement of their B-cell malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Joerg Herrmann, MD
About this study
Official title: 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 evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Chronic Lymphocytic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
- Being tested
- Non-Interventional Study
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular events (MACE)
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.
Measured: Up to 12 months
Secondary outcomes (2)
Incidence of new and/or worsening hypertension (HTN)
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).
Measured: Up to 12 months
Hemodynamic changes associated with new and/or worsening HTN
Impedance cardiography (ICG) changes from before to after BTKi initiation and anti-HTN therapy implication will be recorded to assess hemodynamic changes.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start5 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joerg Herrmann, MD, Mayo Clinic
- Investigators
- Joerg Herrmann, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151730
- Sponsor's protocol ID
- 23-007083
- Other IDs
- NCI-2023-09519, 23-007083
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-Cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors (HALT) - A Pilot Study
- ClinicalTrials.gov ID
- NCT06151730
- Acronym / sponsor ID
- 23-007083
- Conditions
- Chronic Lymphocytic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with B-cell malignancies on BTKi treatment at Mayo Clinic.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with known central nervous system (CNS) involvement of their B-cell malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Incidence of major adverse cardiovascular events (MACE)
Time frame: 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.
2 secondary outcomes
Incidence of new and/or worsening hypertension (HTN)
Time frame: Up to 12 months
Hemodynamic changes associated with new and/or worsening HTN
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joerg Herrmann, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Hematopoietic and Lymphoid System Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (MACE) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.