An interventional study of CHAMPS-II adapted to adults 60+ years in HCT setting in Leukemia, Lymphoma and Multiple Myeloma, sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by University of Nebraska · Not applicable, Interventional, and Supportive care
Among 1,668 studies in Leukemia with a site in United States — 115 open to participants now, 183 under way, 11 of them phase 3. Leukemia · United States.
Among the 1,668 studies in Leukemia with a site in United States, this one is the 223rd largest by planned enrollment of the 1,350 interventional ones that give a count, is one of 31 that started in 2021, is one of 147 with no phase, reaches primary completion later than 90 of the 180 other live ones, and was the 1,529th registered.
2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.
Browse Leukemia studies →115 of the 1,668 studies in Leukemia with a site in United States are open now. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
Ages 18+
Charm Therapeutics · Sites in United States, United Kingdom
Ages 18+
Rutgers, The State University of New Jersey · Sites in United States
Ages 18–110 · Healthy volunteers
Laguna Biotherapeutics, Inc. · Sites in United States
Ages 18 mo–39 yrs
Massachusetts General Hospital · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 208 Leukemia studies recruiting now, 112 (54%) set no upper age limit and 74 (36%) stop at 75 or younger; 86 take children under 18; 24 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,668 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 617 · Phase 2 827 · Phase 3 123 · Phase 4 12
First in 1986; this study’s year is marked. 31 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 114 is above the median of 40 across 1,769 interventional studies indexed under Leukemia.
Median enrollment 35 across the 1,350 interventional studies, 150 across the 153 observational. Of the 1,394 that completed or were terminated, 545 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
313 of 1,668 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 66 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 8 studies filed under Leukemia — fewer than ten, so there is no comparison to draw.
55 of the studies in Leukemia with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07504458Phase 3Quetzal TherapeuticsPivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia | 2027-03 |
| NCT03836261Phase 3Acerta Pharma BVStudy of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL | 2027-04-30 |
| NCT04256317Phase 3Taiho Oncology, Inc.A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | 2027-11-01 |
| NCT05745285University of MiamiLeukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care | 2026-11-30 |
| NCT06152809Dana-Farber Cancer InstituteCIML NK Cells With Venetoclax for AML | 2026-11-30 |
Add all 55 to your calendar (.ics) → With an account.
Among the 1,668 studies in Leukemia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population.
The study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners.
The second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.
Hematologic malignancies are diseases that primarily affect older adults, with a median age at diagnosis of 65 years. Hematopoietic cell transplantation (HCT) is a potentially curative and life-prolonging treatment for patients with hematologic malignancies. Cancer and treatment-related cognitive changes cause distress, hinder resumption of normal routine and roles, and worsen quality of life. HCT differs from the delivery of chemotherapy in other cancer settings due to the intensity of chemotherapy and severity of toxicity. Older adults undergoing HCT are at high risk for cognitive decline and pervasive cognitive deficits. Interventions to improve cognitive outcomes are needed. The prevalence and risk of cognitive decline post-HCT are greater for older adults because of a greater number of existing health conditions (i.e., vascular disease) and impaired physical and psychologic function pre-HCT that can be exacerbated by treatment and the overall HCT experience.
Exercise training improves cancer-related health outcomes, including cardiorespiratory fitness, inflammation, cancer related fatigue, depressive symptoms, and sleep disturbance. There is consistent evidence showing that physical activity improves cognitive function in older adults and survivors of other cancers. Improvement in cardiorespiratory fitness, brain structure, and inflammation underlie the mechanisms of the cognitive benefits of physical activity. While untested in older adults undergoing HCT, the investigator hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population.
Physical activity improves the cognitive domains most affected by cancer treatment, namely executive function and working memory. Cognitive function is an important outcome to older adults and has not been a focus of physical activity interventions in the HCT population. In addition, older adults are underrepresented in previous physical activity interventions in the HCT population.
Investigators will adapt CHAMPS II, an evidence-based physical activity intervention, to the HCT setting for older adults to improve cognitive function. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. The program provides a foundation for application by including an instructor manual and directions for implementation. CHAMPS-II has been adapted and implemented in diverse communities using existing resources and improving contextual factors to increase physical activity for sedentary older adults.
Adaptation of evidence-based interventions, such as CHAMPS-II, can result in an attenuation of effects if the core components are not maintained. However, adaptations can be made to fit the needs and priorities of the service setting, target audience, mode of delivery, and cultural context without compromising CHAMPS-II effectiveness. Through a research-practice partnership approach, investigators will help adapt the program while maintaining the core components of CHAMPS-II, develop new program materials, provide training, monitor implementation, and conduct program evaluation. The overarching goal is to enable HCT team members to implement CHAMPS-II and leverage existing organizational resources to enhance feasibility and sustainability.
The research plan proposes a hybrid effectiveness-implementation design, which is a design that spans the effectiveness and implementation research to accelerate the translation of physical activity interventions into practice for older adults with cancer. This novel trial design will allow testing of the program within a randomized clinical trial methodology while observing and gathering information on implementation. The effectiveness study condition offers an ideal opportunity to examine implementation issues and plan for implementation strategies for a future study that examines both effectiveness and implementation strategies. The study will use the RE-AIM (Reach, Effectiveness - Adoption, Implementation, and Maintenance) framework for planning and formative and process evaluation of the intervention. Formative and process evaluation provides information needed to evaluate an intervention's potential for translation into clinical practice.
Investigators aim to understand the prevalence and impact of AD-neuropathology and inflammation on cognitive function and structural brain changes in older adults undergoing HCT. Quantifiable AD-related neuropathology can accumulate silently for decades with no clinical symptoms. Some will have no AD pathology, some will have "silent" AD pathology, and some will have clinically relevant levels of AD pathology. Brain volumes is also a measure of cognitive reserve with many factors that could impact brain volumes including aging, AD, other degenerative diseases, untreated obstructive sleep apnea (OSA), chronic stress, and ethyl alcohol or ethanol abuse (ETOH). Some patients with low brain volumes may have negative AD biomarkers. However, brain volumes may be a good predictor of CRCD. Investigators expect to gain an understanding of the prevalence of between-subject variability in the quantity of AD neuropathology and differences in brain volume. The results of this research will lay the groundwork for future funding opportunities to elucidate the bidirectional mechanisms, prevention and treatment of AD and CRCD in this population.
Arm 1:
Inclusion Criteria for Participants:
Exclusion Criteria for Participants:
Inclusion Criteria for Participants' Care-Partner:
Exclusion Criteria for Participants' Care-Partner:
Inclusion Criteria for Transplant Team Member:
Exclusion Criteria for Transplant Team Member:
Arms 2 and 3:
Inclusion Criteria for Participants:
Exclusion Criteria for Participants:
Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:
Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:
Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months
Inclusion Criteria for Participants' Care-Partner:
Exclusion Criteria for Participants' Care-Partner:
Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:
Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:
o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months
Inclusion Criteria for Transplant Team Member:
Exclusion Criteria for Transplant Team Member:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Aim 1 will participate in qualitative interviews to obtain feedback on the CHAMPS-II intervention and survivorship education active control condition materials. Interviews will be with 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members.
All participants in Aim 2 (preliminary testing) and Aim 3 (RCT) will participate in the CHAMPS-II physical activity program adapted to the HCT setting. Testing for outcome measures will be completed, and feedback on the intervention will be obtained via qualitative interviews from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members. Aim 3 participants will be randomized to either the immediate intervention (intervention then follow-up) or delayed intervention (wait period and then intervention).
Behavioral: CHAMPS-II adapted to adults 60+ years in HCT setting
CHAMPS-II is an evidence-based physical activity program designed to increase physical activity in sedentary older adults with multiple chronic health conditions. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. Participants will engage in progressive, light to moderate-intensity physical activity throughout the HCT process, with the support of physical therapists, physical activity counselors, and their care-partner. They will take part in supervised exercise sessions; unsupervised exercise sessions; counseling sessions to address barriers, motivators, goals, and safety; and receive telephone support. Walking is the primary mode of aerobic activity, with training in flexibility, strengthening and balance exercises also included. An exercise kit will be provided, consisting of an intervention workbook, therapeutic resistance bands, and activity logs.
Change in executive function as measured by Trails A.
Change in raw scores and z-scores, determined by the following neuropsychological test: Trail Making Test Part A (Trails A). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Time frame: 12 weeks
Change in executive function as measured by Trails B.
Change in raw scores and z-scores, determined by the following neuropsychological tests: Trail Making Test Part B (Trails B). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Time frame: 12 weeks
Change in executive function as measured by the Controlled Oral Word Association Test (COWAT).
Change in raw scores and z-scores, determined by the following neuropsychological test: Controlled Oral Word Association Test (COWAT). Minimum score is zero and maximum is unlimited; higher score means better outcome.
Time frame: 12 weeks
Change in working memory as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Change in raw scores and z-scores, determined by the following neuropsychological test: Hopkins Verbal Learning Test-Revised (HVLT-R). There are 3 learning trials and 1 delayed recall trial. Minimum score for each is zero and maximum is 12; higher score means better outcome. There is also a delayed recognition trial where person is presented with both true positives and false positives. Minimum score for both is zero and maximum is 12. For the true positives a higher score means better outcome. For the false positives a lower score means better outcome.
Time frame: 12 weeks
Change in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA).
Change in total score, determined by objective measures of global cognitive function using the Montreal Cognitive Assessment (MoCA). Minimum score is zero and maximum is 30; higher score means better outcome.
Time frame: 12 weeks
Change in subjective memory as measured by the Neuro-Quality of Life (QOL) Cognition Function-Short Form.
Change in total score, determined by patient questionnaire: Neuro-Quality of Life (QOL) Cognition Function-Short Form. Minimum score is 8 and maximum score is 40; higher score means better outcome.
Time frame: 12 weeks
Change in functional ability as measured by the Short Performance Physical Battery (SPPB).
Change in total score, determined by objective measures of balance, gait speed and endurance with the Short Performance Physical Battery (SPPB). Minimum score is zero, maximum is 12; higher score means better outcome.
Time frame: 12 weeks
Change in endurance as measured by the 6-minute walk.
Change in distance measured in meters, determined by a 6-minute walk. More distance in meters is better outcome.
Time frame: 12 weeks
Change in performance of instrumental activities of daily living as measured by the Lawton Instrumental Activities of Daily Living (IADL).
Change in total score, determined by a self-report questionnaire: Lawton Instrumental Activities of Daily Living (Lawton IADL). Minimum score is zero, maximum is 8; higher score means better outcome.
Time frame: 12 weeks
Change in physical activity as measured by the Community Healthy Activities Model Program for Seniors II (CHAMPS-II) questionnaire.
Change in total score of light and moderate physical activity as measured by a self-report questionnaire (CHAMPS-II questionnaire). Frequency and duration of various intensity activities and their caloric expenditure per week are all scored. No activity, duration or calories expended would be minimum score, and unlimited would be the maximum; where more frequency, duration and calories expended would be a better outcome.
Time frame: 12 weeks
Change in physical activity as measured by the activPAL4 accelerometer data.
Change in time spent in upright postural allocation as measured by an accelerometer (activPAL4). Increased time in upright postural allocation is better outcome.
Time frame: 12 weeks
Change in brain volume as measured by MRI brain.
The focal measures collected for this study include structural atrophy of the hippocampus and cortical thickness of neocortical regions reflecting neurodegeneration (AD-related atrophy), as assessed with high-resolution anatomical MRI.
Time frame: 52 weeks
Change in AD biomarkers as measured by plasma Tau and p-Tau 217.
The characteristic neurofibrillary tangles of AD are composed of pathological tau proteins. Two different measures of tau will be obtained: total tau and phosphorylated tau 217 (p Tau-217). Total tau will be assayed with a Quanterix Simoa Tau 2.1 Kit. The design of this assay identifies all isoforms of the tau protein, hence "total tau". Phosphorylated tau-217 (p-Tau 217) will be assayed with a Quanterix ALZPath Simoa p-Tau217 V2 Assay Service.
Time frame: 52 weeks
Change in biomarkers of inflammation as measured by IL6, IL8, IL10, TNF alpha, and CRP.
Quanterix will measure IL-6, IL-8, IL-10 and TNFa via a Kit Hu 4-Plex SP-116 for cytokines, and C-reactive protein (CRP) via a Simoa CRP Developer Kit.
Time frame: 52 weeks
Presence or absence of AD-related neuropathology as measured by APOE e4 carrier status.
AD genotyping for APOE alleles will be collected via a saliva swab. Apolipoprotein E (APOE) is a complex glycolipoprotein that facilitates the uptake, transport, and distribution of lipids. Numerous studies have shown cognitive vulnerability in non-demented APOE-e4 carriers relative to non-APOE-e4 carriers. APOE will be processed by Salimetrix.
Time frame: Baseline pre-HCT
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Jul 2027, 68 months after the start.
Of 103 non-industry interventional studies with no phase under Leukemia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 128. This study's planned 68 months is above that.
Counting every sponsor, half of 110 studies reached it within 38 months; a quarter within 22 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.