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NCT Number: NCT07558057

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

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Key information

Conditions

Malignant Lymphoma - Lymphoplasmacytic Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Neuropsychological tests and patient reported outcome

Other

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.

Primary outcomes

  1. Cancer related cognitive impairment (CRCI)

    Time frame: Day 0, month 3, month 6, month 12, month 24, month 36

    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.

Secondary outcomes

  1. Overall and progression-free survival

    Time frame: 3 years

    Overall and progression-free survival

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

    Time frame: 3 years

    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)

  3. Return to work (RTW)

    Time frame: 3 years

    Return to work/occupational status

    Day 0 the following data is collected:

    • Self-employed
    • Employee
    • Working full time
    • Working part time (hours/week)
    • Unemployed
    • On sick leave
    • Early retirement
    • Pensioner
    • Dismissed
    • Disability or anticipatory pensioner
    • Enrolled in education
    • Continue studies during the treatment
    • Pausing studies during the treatment
    • Dropped out of study/education
    • 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Acronym: COGNITOX

Important dates

Study start
2026
Primary completion
2032
Study completion
2034
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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