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Recurrent B-Cell Non-Hodgkin LymphomaNCT07609030

A Cognitive Training Intervention for Improving Cognitive and Neurological Outcomes in Patients Undergoing Treatment for Relapsed or Refractory Multiple Myeloma or B-cell Non-Hodgkin Lymphoma

A study testing Biospecimen Collection, Cognitive Intervention and Electronic Health Record Review in people with Recurrent B-Cell Non-Hodgkin Lymphoma and Recurrent Multiple Myeloma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial evaluates whether an online cognitive training intervention (Intervention to enhance Cognitive Augmentation and Neuroplasticity [I-CAN]), delivered before and after treatment with chimeric antigen receptor T-cell therapy, works to improve cognitive and neurological outcomes in patients with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cognitive Intervention and Electronic Health Record Review
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
28 Apr 2026to 31 Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients >= 18 years of age
  • Diagnosed with relapsed/refractory multiple myeloma (MM) or B-cell non-Hodgkin lymphoma (B-NHL)
  • Expected to receive an Food and Drug administration (FDA)-approved CAR-T cellular treatment
  • English literacy

Who cannot join

  • Patients expected to live < 6 months
  • Patients with major medical disorder known to affect cognition, such as stroke, encephalitis, traumatic brain injury, brain surgery
  • Confirmed Alzheimer disease or other dementia
  • Previous central nervous system (CNS) radiation
  • Active intrathecal therapy at time of enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Ashley E. Rosko, MD, 614-688-7397, Ashley.Rosko@osumc.edu

    Ashley E. Rosko, MD

    Recruiting

Other trials in United States

About this study

Official title: Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)

This clinical trial evaluates whether an online cognitive training intervention (Intervention to enhance Cognitive Augmentation and Neuroplasticity [I-CAN]), delivered before and after treatment with chimeric antigen receptor T-cell therapy, works to improve cognitive and neurological outcomes in patients with multiple myeloma or B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Cancer treatment can have significant short and long-term side effects, including cognitive and neurological side effects such as impairments in attention, memory, language, and executive function. The I-CAN program is a form of cognitive training. Cognitive training is a therapeutic approach designed to improve and restore cognitive functioning, based on the brain's ability to reorganize and form new neural connections to accomplish tasks. I-CAN provides five core elements necessary for training the brain to create new neural connections including speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. The I-CAN intervention, when delivered before and after therapy, may help reduce the cognitive side effects of treatment in patients with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To conduct a prospective single arm study of an Intervention to enhance Cognitive Augmentation and Neuroplasticity (I-CAN) program in 90 patients with relapsed B-cell hematologic malignancy receiving chimeric antigen receptor-T cell therapy (CAR-T).

SECONDARY OBJECTIVES:

  1. To examine the neurocognitive change (Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment [FACT-Cog PCI]; Montreal Cognitive Assessment [MoCA]) from baseline, following the I-CAN program at timepoint 2 (T2)-timepoint 5 (T5) in CAR T recipients.

II. To examine the relationship of higher-grade neurotoxicity/cytokine release syndrome (CRS) with change in neurocognitive measures (FACT-Cog PCI, MoCA) from baseline, following the I-CAN program at T2-T5 in CAR T recipients.

III. To examine the change in distress (anxiety and depression) and frailty (Fried Frailty Phenotype) from baseline, following the I-CAN program at T2-T5 in CAR-T recipients.

IV. To determine the change in molecular markers of aging (Ohio State University [OSU] Senescence, epigenetic clock/DNAge, inflammatory cytokines, changes in peripheral blood T lymphocyte subsets) before and after CAR-T.

  1. To examine the association of molecular markers of aging with cognition and frailty (FACT-Cog PCI, Fried Frailty Phenotype) as well as other prognostic factors (e.g. age, disease, CRS/neurotoxicity) before and after CAR-T.

VI. To explore the impact of the ICAN program on healthcare utilization (hospital re/admissions, emergency department visits) compared to age and diagnostic-matched historic control from baseline to T5 and examine return to work (role function/work productivity/absenteeism) at each time point, timepoint 1 (T1)-T5.

OUTLINE:

Patients participate in online I-CAN training sessions over approximately 2.5 hours per week for 4 weeks before and 4 weeks after CAR-T therapy for a total of 20 hours over 8 weeks. Patients also undergo collection of blood samples throughout the study.

After completion of study treatment, patients are followed up at 1, 3, and 12 months post-infusion.

Being tested
Biospecimen Collection, Cognitive Intervention, Electronic Health Record Review, Survey Administration
Medical subject headings
Lymphoma, B-Cell, Multiple Myeloma

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 samples

  • Cognitive InterventionOther

    Participate in I-CAN training sessions

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07609030
Study groupRoleWhat they receive
Supportive care (I-CAN)ExperimentalPatients participate in online I-CAN training sessions over approximately 2.5 hours per week for 4 weeks before and 4 weeks after CAR-T therapy for a total of 20 hours over 8 weeks. Patients also undergo collection of blood samples throughout the study.
Receives: Procedure: Biospecimen Collection; Other: Cognitive Intervention; Other: Electronic Health Record Review; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility)

    Descriptive statistics will be used to examine adherence, defined as the percent completion of I-CAN cognitive training before and after infusion.

    Measured: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)

  2. Retention

    Descriptive statistics will be used to examine retention, defined as % follow-up assessments completed.

    Measured: 12 months post-infusion, up to 14 months

  3. I-CAN satisfaction (feasibility)

    Descriptive statistics will be used to examine acceptability, defined as % satisfaction on Client Satisfaction Questionnaire.

    Measured: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)

Secondary outcomes (11)

  1. Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI)

    Descriptive statistics and trend plots will be used to examine the FACT-Cog PCI scores over time. Linear mixed models (LMM) for repeated measures will be used to model each neurocognitive measure (FACT-Cog-PCI scores) as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures.

    Measured: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)

  2. Change in Montreal Cognitive Assessment (MoCA)

    Descriptive statistics and trend plots will be used to examine the MoCA scores over time. LMM for repeated measures will be used to model each neurocognitive measure (MoCA scores) as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures.

    Measured: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)

  3. Change in depression

    Evaluated by 20-item Center for Epidemiological Studies Depression Scale. Descriptive statistics and trend plots will be used to examine changes over time. LMM for repeated measures will be used to model each outcome as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures.

    Measured: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)

  4. Change in anxiety

    Evaluated by 8-item Patient-Reported Outcomes Measurement Information System Short Form version1.0 - Anxiety 8a. Descriptive statistics and trend plots will be used to examine changes over time. LMM for repeated measures will be used to model each outcome as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures.

    Measured: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)

  5. Change in frailty

    Evaluated using Fried's frailty phenotype. Descriptive statistics and trend plots will be used to examine changes over time. LMM for repeated measures will be used to model each outcome as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures.

    Measured: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)

  6. Healthcare utilization (Number of ER visits)

    Number of ER visits for each participant will be assessed at each time point. Data will be collated by review of medical records.

    Measured: Up to 14 months

  7. Healthcare utilization (Hospital admissions/readmissions)

    Number of hospital admissions / readmissions for each participant will be assessed at each time point. Data will be collated by review of medical records.

    Measured: Up to 14 months

  8. Healthcare utilization (Length of Hospital Stay)

    Length of hospital stay for each participant admitted to the hospital will be assessed at each time point. Data will be collated by review of medical records.

    Measured: Up to 14 months

  9. Return to function

    Return to work compared to published data will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (physical functioning, social functioning, role functioning).

    Measured: Up to 14 months

  10. Direct and indirect costs

    Economic evaluation of direct medical costs of healthcare utilization and indirect costs of age-specific work ability/productivity gains/losses.

    Measured: Up to 14 months

  11. Income changes due to changes in work productivity

    Income changes due to changes in work productivity will be estimated using annual salaries calculated based on educational attainment-matched national averages obtained from Current Population Survey Annual Social and Economic Supplements conducted by the United States Census Bureau.

    Measured: Up to 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start28 Apr 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609030
Sponsor's protocol ID
OSU-25086
Other IDs
NCI-2026-03016
Status last verified
May 2026
First submitted
2 May 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Cognitive Intervention and Electronic Health Record Review in people with Recurrent B-Cell Non-Hodgkin Lymphoma and Recurrent Multiple Myeloma, run by Ohio State University Comprehensive Cancer Center 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 4 inclusion and 5 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 May 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 The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility) (time frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07609030.

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 May 2026.

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