Cognitive Impairment in Patients Undergoing Cell- and Antibody-based Immunotherapies for Haematological Malignancies: The COGNITOX Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuropsychological tests and patient reported outcome.
- Who it may be relevant to
- Registry conditions: Malignant Lymphoma - Lymphoplasmacytic, Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Neuropsychological tests and patient reported outcome
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 approximatel
Primary outcome measures
- Cancer related cognitive impairment (CRCI) [Time frame: Day 0, month 3, month 6, month 12, month 24, month 36]
Secondary outcome measures (3)
- Overall and progression-free survival [Time frame: 3 years]
- Health related quality of life (HM-PRO score) [Time frame: 3 years]
- Return to work (RTW) [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT07558057 · File nr. 1-10-72-128-25 · Ethics