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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Cancer related cognitive impairment (CRCI) — 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.

Trial sites (1)

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