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

April 22, 2026 updated by: Aarhus University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
        • Contact:
          • Astrid Lindman, PhD, MScH, RN, clinical spec.
          • Phone Number: +45 24900046
          • Email: astrlind@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, month 3, month 6, month 12, month 24, month 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall and progression-free survival
Time Frame: 3 years
Overall and progression-free survival
3 years
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 years
Return to work (RTW)
Time Frame: 3 years

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

    1. Continue studies during the treatment
    2. Pausing studies during the treatment
    3. Dropped out of study/education
  12. 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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

March 31, 2032

Study Completion (Estimated)

March 31, 2034

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • File nr. 1-10-72-128-25
  • Ethics (Other Identifier: The Central Denmark Region Committees on Health Research Ethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malignant Lymphoma - Lymphoplasmacytic

Clinical Trials on Neuropsychological tests and patient reported outcome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe