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Cognitive Impairment in Patients With Diffuse Large B-Cell Lymphoma

ConditionDiffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana

About this trial

This prospective, non-randomized diagnostic interventional study evaluates cognitive impairment in patients with diffuse large B-cell lymphoma (DLBCL) treated at the Institute of Oncology Ljubljana. Chemotherapy regimens are administered according to clinical indication and are not assigned by the study protocol.

The research intervention consists of structured neurocognitive assessments and biomarker analyses performed at predefined time points during treatment and follow-up. Cognitive function will be assessed at baseline, after the first chemotherapy cycle, and 12 months after treatment initiation. In patients receiving intrathecal chemotherapy, cerebrospinal fluid (CSF) biomarkers will be analyzed using samples collected during clinically indicated lumbar punctures.

The study aims to characterize the frequency, severity, and trajectory of cognitive impairment and to identify clinical and biological predictors of treatment-associated cognitive changes in patients with DLBCL.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 to 80 years

Newly diagnosed diffuse large B-cell lymphoma (DLBCL) planned for treatment with systemic chemotherapy (R-CHOP) with or without intrathecal chemotherapy

Ability to provide written informed consent

For healthy volunteer/control group: relatives of participating patients willing to undergo cognitive testing and questionnaires

Disqualifiers

Severe cognitive impairment preventing completion of neurocognitive testing

Severe psychiatric disorder or neurological disease interfering with cognitive assessment

Inability to understand study procedures or complete questionnaires

Refusal or inability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured Neurocognitive Assessment Battery

    Diagnostic test

    Standardized neurocognitive testing including Montreal Cognitive Assessment (MoCA), Short Cognitive Performance Test (KPSS), and selected CANTAB computerized tasks assessing attention, working memory, executive function, processing speed, and episodic memory. Assessments are performed at baseline (prior to treatment initiation), after the first chemotherapy cycle, and 12 months after treatment initiation.

  • Psychometric Questionnaires

    Diagnostic test

    Validated questionnaires assessing anxiety, depression, fatigue, cognitive complaints, and quality of life (HADS, HAM-D, FSS, FACT-Cog v3, EORTC QLQ-C30, ECOG Performance Status). Questionnaires are administered at predefined study time points.

  • CSF Biomarker Analysis

    Diagnostic test

    Quantification of cerebrospinal fluid biomarkers (phosphorylated tau, total tau, amyloid beta 40, amyloid beta 42, neurofilament light chain, GFAP). CSF samples are collected during clinically indicated lumbar punctures prior to intrathecal chemotherapy administration. No additional lumbar punctures are performed solely for research purposes.

Treatment groups

3 Participants
are divided into 3 treatment groups
Group A: DLBCL - Systemic Chemotherapy (R-CHOP)Experimental treatment 2 interventions
Group B: DLBCL - Systemic + Intrathecal ChemotherapyExperimental treatment 3 interventions
Group C: Healthy Control Group (Relatives)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cognitive Function (MoCA Total Score)

Change in MoCA total score from baseline across follow-up assessments.

Time frame
Baseline (within 7 days prior to treatment initiation)
2

Change in Cognitive Function (MoCA Total Score)

Change in MoCA total score from baseline across follow-up assessments.

Time frame
After first chemotherapy cycle (Cycle 1 Day 14-21)
3

Change in Cognitive Function (MoCA Total Score)

Change in MoCA total score from baseline across follow-up assessments.

Time frame
12 months after treatment initiation (±4 weeks).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Oncology Ljubljana

Lead sponsor

Source ClinicalTrials.gov
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