Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaNCT05876923
The Effects of Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients
A study testing Biospecimen Collection, Cardiopulmonary Exercise Testing and Dual X-ray Absorptiometry in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Indolent Non-hodgkin Lymphoma, run by Mayo Clinic at 2 sites in United States.
Trial summary
This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent Non-hodgkin Lymphoma
- What is being tested?
- Biospecimen Collection, Cardiopulmonary Exercise Testing and Dual X-ray Absorptiometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jun 2023to Apr 2028
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Between the ages of 18-80
- Histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study
Who cannot join
- Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g. heart disease, coronary artery disease, chronic obstructive pulmonary disease [COPD], asthma, etc.) an orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker
- Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those who have already received treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals that are participating prior to receiving treatment must not have any scheduled treatments during their participation. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Briana Ziegler, 507-255-7125, zeigler.briana@mayo.edu
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Jordan Parks, 480-301-6616, parks.jordan@mayo.edu
About this study
Official title: The Effects of Acute and Chronic Exercise on the Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients
This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of CLL patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.
II. Determine how circulating immune cell mobilization and function (cell counts \& cytokine profile) of CLL patients respond to a 12-week semi-supervised training program of moderate to high intensity, aerobic based exercise.
III. Evaluate the effectiveness of 12-weeks of semi-supervised exercise training (ET) versus (vs.) usual care (UC) at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent non-Hodgkin (NHL) lymphoma during or after treatment.
IV. Determine that extent to which 12-weeks of semi-supervised ET can modify circulating immune cell mobilization and immune function in individuals with indolent NHL during or after treatment compared to UC.
- Development of a forward-chaining AI expert system using both manual and physiology derived feedback to optimize training results and compare its efficacy at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent NHL and CLL to that of the semi-supervised ET.
OUTLINE: CLL patients and healthy participants are assigned to Aim 1. CLL patients who complete all Aim 1 activities are assigned to Aim 2. Patients with indolent NHL will be assigned to Aims 3 and 4.
AIM 1: Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (cardiopulmonary exercise testing [CPET]), and undergo collection of blood samples on study. Participants may also undergo dual X-ray absorptiometry (DEXA) scan on study.
AIM 2: CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.
AIMS 3-4: Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6-minute walk test (6MWT). Patients are then randomized to 1 of 2 arms.
ARM I: Patients receive usual care on study.
ARM II: Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.
AIM 5: All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.
After completion of study intervention, patients are followed up every 6 months (Aims 2-4) or annually (Aim 5) for 3 years.
- Being tested
- Biospecimen Collection, Cardiopulmonary Exercise Testing, Dual X-ray Absorptiometry, Electronic Health Record Review, Exercise Intervention
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood
Cardiopulmonary Exercise TestingOther
Also called CPET, CPX
Undergo CPET
Dual X-ray AbsorptiometryProcedure or surgery
Also called BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)
Undergo DEXA scan
Electronic Health Record ReviewOther
Ancillary studies
Undergo aerobic based training program
Physical ExaminationProcedure or surgery
Also called Assessment, General Examination, Physical, Physical Assessment
Undergo measurement of height/weight and vital signs
Questionnaire AdministrationOther
Ancillary studies
SpirometryProcedure or surgery
Undergo spirometry
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Undergo muscular strength and functional endurance measurements
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 (vitals, spirometry, CPET, blood samples, DEXA) | Experimental | Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Receives: Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry |
| Aim 2 (aerobic based training program, Aim 1 activities) | Experimental | CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program. Receives: Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Exercise Intervention; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry |
| Aims 3-4 arm I (indolent NHL usual care) | Active comparator | Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients receive usual care on study. Receives: Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry; Other: Physical Performance Testing; Other: Best Practice |
| Aims 3-4 arm II (indolent NHL aerobic based training program) | Active comparator | Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program. Receives: Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Exercise Intervention; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry; Other: Physical Performance Testing; Other: Best Practice |
| Aim 5 (repeat baseline activities) | Experimental | All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities. Receives: Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry; Other: Physical Performance Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess circulating immune cell abundance and function pre-intervention
A standardized questionnaire will be administered to assess levels of past and current physical activity. Baseline measurement of pulmonary function (PFT) will be collected and possibly a body composition scan via dual x-ray absorptiometry (DEXA). While subjects perform cardiopulmonary exercise testing (CPET), cardiopulmonary vitals will be assessed and monitored throughout exercise and in recovery. A 40 mL venous blood sample will be drawn at baseline and post exercise (80 mL total), along with finger prick measures of blood lactate at rest and early recovery. Blood samples will be evaluated to determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of chronic lymphocytic leukemia (CLL) patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.
Measured: Baseline
Assess circulating immune cell mobilization and function post-intervention
Each subject will participate in a 12-weeks exercise program (3 times per week) at a moderate to high exercise intensity level based upon the results of their cardiopulmonary exercise testing (CPET)]. Upon completion of the program, subjects will return to the laboratory for post testing using the same techniques as used during the baseline. Venous blood samples drawn at rest after the program will be used to determine how circulating immune cell mobilization and function (cell counts and cytokine profile) of CLL patients respond to intervention. Usual descriptive statistics will be performed - means, standard deviations, and ranges. Comparisons within a group over time or pre/post will be performed using paired t-tests, while comparisons between groups will be performed using unpaired t-tests or where necessary using ANOVA. Comparisons will be made based on absolute values as well as changes during a test.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start12 Jun 2023
- Primary completion13 Mar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael P. Gustafson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876923
- Sponsor's protocol ID
- 22-012246
- Other IDs
- NCI-2023-03210, 22-012246
- Status last verified
- Apr 2026
- First submitted
- 1 May 2023
- Last updated
- 9 Apr 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute and Chronic Exercise on the Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients
- ClinicalTrials.gov ID
- NCT05876923
- Acronym / sponsor ID
- 22-012246
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 13 Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 26 May 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 clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.
Detailed description
PRIMARY OBJECTIVES:
- Determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of CLL patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.
II. Determine how circulating immune cell mobilization and function (cell counts \& cytokine profile) of CLL patients respond to a 12-week semi-supervised training program of moderate to high intensity, aerobic based exercise.
III. Evaluate the effectiveness of 12-weeks of semi-supervised exercise training (ET) versus (vs.) usual care (UC) at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent non-Hodgkin (NHL) lymphoma during or after treatment.
IV. Determine that extent to which 12-weeks of semi-supervised ET can modify circulating immune cell mobilization and immune function in individuals with indolent NHL during or after treatment compared to UC.
- Development of a forward-chaining AI expert system using both manual and physiology derived feedback to optimize training results and compare its efficacy at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent NHL and CLL to that of the semi-supervised ET.
OUTLINE: CLL patients and healthy participants are assigned to Aim 1. CLL patients who complete all Aim 1 activities are assigned to Aim 2. Patients with indolent NHL will be assigned to Aims 3 and 4.
AIM 1: Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (cardiopulmonary exercise testing [CPET]), and undergo collection of blood samples on study. Participants may also undergo dual X-ray absorptiometry (DEXA) scan on study.
AIM 2: CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.
AIMS 3-4: Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6-minute walk test (6MWT). Patients are then randomized to 1 of 2 arms.
ARM I: Patients receive usual care on study.
ARM II: Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.
AIM 5: All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.
After completion of study intervention, patients are followed up every 6 months (Aims 2-4) or annually (Aim 5) for 3 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Aim 1 (vitals, spirometry, CPET, blood samples, DEXA) | Experimental | Procedure: Biospecimen Collection, Other: Cardiopulmonary Exercise Testing, Procedure: Dual X-ray Absorptiometry, Other: Electronic Health Record Review, Procedure: Physical Examination, Other: Questionnaire Administration, Procedure: SpirometryParticipants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. |
| Aim 2 (aerobic based training program, Aim 1 activities) | Experimental | Procedure: Biospecimen Collection, Other: Cardiopulmonary Exercise Testing, Procedure: Dual X-ray Absorptiometry, Other: Electronic Health Record Review, Other: Exercise Intervention, Procedure: Physical Examination, Other: Questionnaire Administration, Procedure: SpirometryCLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program. |
| Aims 3-4 arm I (indolent NHL usual care) | Active comparator | Procedure: Biospecimen Collection, Other: Cardiopulmonary Exercise Testing, Procedure: Dual X-ray Absorptiometry, Other: Electronic Health Record Review, Procedure: Physical Examination, Other: Questionnaire Administration, Procedure: Spirometry, Other: Physical Performance Testing, Other: Best PracticeIndolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients receive usual care on study. |
| Aims 3-4 arm II (indolent NHL aerobic based training program) | Active comparator | Procedure: Biospecimen Collection, Other: Cardiopulmonary Exercise Testing, Procedure: Dual X-ray Absorptiometry, Other: Electronic Health Record Review, Other: Exercise Intervention, Procedure: Physical Examination, Other: Questionnaire Administration, Procedure: Spirometry, Other: Physical Performance Testing, Other: Best PracticeIndolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program. |
| Aim 5 (repeat baseline activities) | Experimental | Procedure: Biospecimen Collection, Other: Cardiopulmonary Exercise Testing, Procedure: Dual X-ray Absorptiometry, Other: Electronic Health Record Review, Procedure: Physical Examination, Other: Questionnaire Administration, Procedure: Spirometry, Other: Physical Performance TestingAll patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Between the ages of 18-80
- Histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study
Key exclusion criteria (2 listed)
- Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g. heart disease, coronary artery disease, chronic obstructive pulmonary disease [COPD], asthma, etc.) an orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker
- Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those who have already received treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals that are participating prior to receiving treatment must not have any scheduled treatments during their participation. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood | Procedure or surgery | Aim 1 (vitals, spirometry, CPET, blood samples, DEXA), Aim 2 (aerobic based training program, Aim 1 activities), Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Cardiopulmonary Exercise TestingAlso: CPET, CPXUndergo CPET | Other | Aim 1 (vitals, spirometry, CPET, blood samples, DEXA), Aim 2 (aerobic based training program, Aim 1 activities), Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Dual X-ray AbsorptiometryAlso: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)Undergo DEXA scan | Procedure or surgery | Aim 1 (vitals, spirometry, CPET, blood samples, DEXA), Aim 2 (aerobic based training program, Aim 1 activities), Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Electronic Health Record ReviewAncillary studies | Other | Aim 1 (vitals, spirometry, CPET, blood samples, DEXA), Aim 2 (aerobic based training program, Aim 1 activities), Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Exercise InterventionUndergo aerobic based training program | Other | Aim 2 (aerobic based training program, Aim 1 activities), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Physical ExaminationAlso: Assessment, General Examination, Physical, Physical AssessmentUndergo measurement of height/weight and vital signs | Procedure or surgery | Aim 1 (vitals, spirometry, CPET, blood samples, DEXA), Aim 2 (aerobic based training program, Aim 1 activities), Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Questionnaire AdministrationAncillary studies | Other | Aim 1 (vitals, spirometry, CPET, blood samples, DEXA), Aim 2 (aerobic based training program, Aim 1 activities), Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| SpirometryUndergo spirometry | Procedure or surgery | Aim 1 (vitals, spirometry, CPET, blood samples, DEXA), Aim 2 (aerobic based training program, Aim 1 activities), Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingUndergo muscular strength and functional endurance measurements | Other | Aim 5 (repeat baseline activities), Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Aims 3-4 arm I (indolent NHL usual care), Aims 3-4 arm II (indolent NHL aerobic based training program) |
Primary outcome
Assess circulating immune cell abundance and function pre-intervention
Time frame: Baseline
A standardized questionnaire will be administered to assess levels of past and current physical activity. Baseline measurement of pulmonary function (PFT) will be collected and possibly a body composition scan via dual x-ray absorptiometry (DEXA). While subjects perform cardiopulmonary exercise testing (CPET), cardiopulmonary vitals will be assessed and monitored throughout exercise and in recovery. A 40 mL venous blood sample will be drawn at baseline and post exercise (80 mL total), along with finger prick measures of blood lactate at rest and early recovery. Blood samples will be evaluated to determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of chronic lymphocytic leukemia (CLL) patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.
Assess circulating immune cell mobilization and function post-intervention
Time frame: Up to 12 weeks
Each subject will participate in a 12-weeks exercise program (3 times per week) at a moderate to high exercise intensity level based upon the results of their cardiopulmonary exercise testing (CPET)]. Upon completion of the program, subjects will return to the laboratory for post testing using the same techniques as used during the baseline. Venous blood samples drawn at rest after the program will be used to determine how circulating immune cell mobilization and function (cell counts and cytokine profile) of CLL patients respond to intervention. Usual descriptive statistics will be performed - means, standard deviations, and ranges. Comparisons within a group over time or pre/post will be performed using paired t-tests, while comparisons between groups will be performed using unpaired t-tests or where necessary using ANOVA. Comparisons will be made based on absolute values as well as changes during a test.
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 9 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
RecruitingPhase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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.
Michael P. Gustafson, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Cardiopulmonary Exercise Testing and Dual X-ray Absorptiometry in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Indolent Non-hodgkin Lymphoma, run by Mayo Clinic at 2 sites 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 3 inclusion and 2 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Assess circulating immune cell abundance and function pre-intervention (time frame: Baseline). The study lists 2 primary outcomes in all. 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 9 Apr 2026.