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Malignant Lymphoma - LymphoplasmacyticCOGNITOXNCT07558057

Cognitive Impairment in Patients Undergoing Cell- and Antibody-based Immunotherapies for Haematological Malignancies: The COGNITOX Study

An observational study of Malignant Lymphoma - Lymphoplasmacytic and Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, run by Aarhus University Hospital at 1 site in Denmark.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Cell- and antibody-based therapies, including chimeric antigen receptor T-cell (CAR-T) therapy and bispecific antibodies, represent significant advances in the treatment of hematologic malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neuropsychological tests and patient reported outcome
How many people
225 participants
Where
1 siteDenmark
Study dates
31 Mar 2026to 31 Mar 2034
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with a malignant haematological disease at the Department of Haematology, Aarhus University Hospital will be enrolled according to the above mentioned treatment subsets and pre-defined inclusion criteria.

Who may be able to join

  • Patients must be ≥ 18 years old
  • Able to speak and read Danish
  • Provide informed consent

Who cannot join

  • CNS-involvement by the haematological malignancy
  • Cognitive impairment due to pre-existing psychiatric or neurological conditions

Trial locations and contacts

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

Denmark1 site

  • Aarhus University Hospital

    Aarhus

    Astrid Lindman, PhD, MScH, RN, clinical spec., +45 24900046, astrlind@rm.dk

Other trials in Denmark

About this study

Cell- and antibody-based therapies, including chimeric antigen receptor T-cell (CAR-T) therapy and bispecific antibodies, represent significant advances in the treatment of hematologic malignancies. These therapies optimise the patient's immune system to target and eliminate malignant cells, achieving profound and durable responses in patients where conventional treatment approaches have failed. However, their mechanism of action-through profound immune activation-introduces a challenging toxicity profile, including cytokine release syndrome and immune effector cell-induced neurotoxicity. Emerging evidence suggests that neurotoxicity associated with these therapies may extend beyond acute symptoms to include persistent cognitive impairments. Such impairments can manifest deficits in memory, attention, executive functioning, and processing speed, potentially compromising patients' quality of life, ability to manage daily activities and return to work.

The COGNITOX project explores the occurrence, clinical manifestations, and impact on quality of life of neuro-psychologically assessed and patient-reported cognitive impairment. The project's data set is generated through standardized neuropsychological tests (recommended by the International Cognition and Cancer) and validated patient reported outcome measures, to evaluate multiple cognitive domains. The project is developed in close collaboration between the Department of Haematology, Aarhus University Hospital and the Unit for Psychooncology and Health Psychology (EPoS), Department of Psychology and Behavioural Sciences, Aarhus University.

The current literature on cognitive impairment secondary to cell- and antibody-based therapies is limited, and none of the studies reported so far were conducted within a Danish healthcare context. Understanding the prevalence, severity, and functional impact of cognitive impairments in this patient population is critical. These insights will inform clinical practice, guide patient counseling, and support the development of targeted interventions aimed at mitigating cognitive decline. By generating robust data, this project seeks to improve the knowledge within the field and lay the foundation for an intervention study addressing the needs of patients undergoing these advanced immunotherapies.

Being tested
Neuropsychological tests and patient reported outcome
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Multiple Myeloma, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuropsychological tests and patient reported outcomeOther

    Cognitive assessments will be conducted by a clinical nurse specialist and/or a project nurse working at the department. Both are trained by expert neuropsychologists (AA and LW). The cognitive assessments will be conducted at baseline, i.e. prior to one of the protocolled cell- or antibody-based immunotherapies, and at 3-, 6-, 12-, 24-, and 36-month after treatment in concomitance with an appointment at the outpatient clinic for planned control visits. The cognitive assessment will approximately take 1-1½ hour. The results of the tests will not be immediately available for the individual patient, because the analysis will be performed on a later set of pooled data. However, patients will be offered a summarized version of the test results at 1-year follow-up.

    In relation to the neurocognitive assessment, patients will also be invited to complete electronic questionnaires.

What is being measured

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

  1. Cancer related cognitive impairment (CRCI)

    The primary endpoint of the study is the occurrence, of cancer related cognitive impairment (CRCI) in patients treated with either chimeric antigen receptor T-cell therapy (CAR-T) or bispecific antibodies (BsAbs) as compared to high dose chemotherapy with autologous haematopoietic stem cell transplantation (AutoHSCT). Clinical manifestations and severity of CRCI will also be reported as descriptive co-primary endpoints.

    Measured: Day 0, month 3, month 6, month 12, month 24, month 36

Secondary outcomes (3)

  1. Overall and progression-free survival

    Overall and progression-free survival

    Measured: 3 years

  2. Health related quality of life (HM-PRO score)

    The HM-PRO has 24 items in Part A and 18 items in Part B. Each question has three response options:

    Part A Not at all (score = 0) A little (1) A lot (2) Not applicable Part B Not at all (score = 0) Mild (1) Severe (2) The score range for Part A is 0-48 and for Part B is 0-36. The higher the total score, the greater the effect on a patient's quality of life.

    The items in the HM-PRO are divided into four categories (domains):

    Physical Behaviour (the first 7 items, maximum score of 14) Social Well-being (the second 3 items, maximum score of 6) Emotional Behaviour (the third 11 items, maximum score of 22) Eating and Drinking (the last 3 items, maximum score of 6)

    HM-PRO Part A score is reported as a single total score HM-PRO A-total, score range 0-48

    The HM-PRO Part A score is also reported as four separate scores:

    HM-PRO Physical, score range 0-14 HM-PRO Social, score range 0-6 HM-PRO Emotional, score range 0-22 HM-PRO Eating/Drinking, score range 0-6 HM-PRO B-total (score range 0-36)

    Measured: 3 years

  3. Return to work (RTW)

    Return to work/occupational status

    Day 0 the following data is collected:

    1. Self-employed
    2. Employee
    3. Working full time
    4. Working part time (hours/week)
    5. Unemployed
    6. On sick leave
    7. Early retirement
    8. Pensioner
    9. Dismissed
    10. Disability or anticipatory pensioner
    11. Enrolled in education
    12. Continue studies during the treatment
    13. Pausing studies during the treatment
    14. Dropped out of study/education
    15. Other

    Data collected at 6-, 12-, 24-, 36-month follow-up:

    • Still on sick leave
    • Dismissed
    • Gradually increasing hours/week. Aiming at return to full time/part time
    • Worked full time or part time at baseline, changed to:

    Working part time or part time, but less hours/week than before

    • Changes in job description (yes/no) if yes: New less responsible job description Other changes in job description
    • Enrolled in education Continue/pausing studies during the cancer treatment and follow-up Completed education Dropped out of study/education
    • Retired
    • Other

    Measured: 3 years

Timeline

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

  1. First posted30 Apr 2026
  2. Study start31 Mar 2026 (estimated)
  3. Primary completion31 Mar 2032 (estimated)
  4. Study completion31 Mar 2034 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07558057
Sponsor's protocol ID
File nr. 1-10-72-128-25
Other IDs
Ethics
Acronym
COGNITOX
Status last verified
Mar 2026
First submitted
10 Mar 2026
Last updated
30 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Lymphoma - Lymphoplasmacytic and Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, run by Aarhus University Hospital at 1 site in Denmark.

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: opening soon, as of the sponsor's last update on 30 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 1 site in Denmark. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer related cognitive impairment (CRCI) (time frame: Day 0, month 3, month 6, month 12, month 24, month 36). 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 NCT07558057.

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 30 Apr 2026.

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