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

NCT07558057 | Not Yet Recruiting

• 2 other identifiers: File nr. 1-10-72-128-25Ethics
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Lymphoma - Lymphoplasmacytic; Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Overall and progression-free survival

  3 years

• Health related quality of life (HM-PRO score)

  3 years

• Return to work (RTW)

  3 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone; Multiple Myeloma; Lymphoma

Interventions

Neuropsychological Tests; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: April 30, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2034
• Last Updated: April 30, 2026

Record last verified: 2026-03

Locations

DK (1)