Diffuse Large B Cell Lymphoma (DLBCL)NEURO_CAR-TNCT07463781
Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy
An observational study of Diffuse Large B Cell Lymphoma (DLBCL) and High Grade B Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 8 sites in Italy.
Trial summary
This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL)
- What is being tested?
- Chimeric Antigen Receptor T-cells (CAR-T) therapy
- How many people
- 100 participants
- Where
- 8 sitesItaly
- Study dates
- May 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High-Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL) scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug
Who may be able to join
- Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High- Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL).
- Patients undergoing CD19-targeted CAR-T cell salvage therapy for relapsed/refractory disease according to AIFA inclusion criteria.
- Age over 18-years-old at the time of lymphoma diagnosis.
Who cannot join
- Patient with histological diagnosis of mantle cell lymphoma (MCL) or acute lymphoblastic leukemia (ALL)
- Patients with CNS disease localization.
- Patients that received brain/neuroaxis radiotherapy.
- Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Italy8 sites
SCDU Ematologia - AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria
Manuela Zanni, manuela.zanni@ospedale.al.it
Clinica di Ematologia, AOU Ospedali Riuniti
Ancona
Guido Gini, guido.gini@ospedaliriuniti.marche.it
USD-TMO Adulti - ASST Spedali Civili di Brescia
Brescia
Michele Malagola, michele.malagola@unibs.it
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo
Luca Castagna, l.castagna@villasofia.it
Ematologia - Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria
Martino Massimo, dr.massimomartino@gmail.com
Ematologia - Università Cattolica S. Cuore
Roma
Simona Sica, simona.sica@unicatt.it
SC Ematologia - Ospedale "S.G. Moscati"
Taranto
Claudia Ingrosso, claudia.ingrosso@asl.taranto.it
SOC Clinica Ematologica - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine
Jacopo Olivieri, jacopo.olivieri@asufc.sanita.fvg.it
About this study
Official title: Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy: a Multicenter Observational Prospective Study
This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. A longitudinal survey will be carried out by collecting patients' data before starting CAR-T (T0) and after 6 (T1), 12 (T2) and 24 (T3) months after CAR-T infusion.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL)
- Being tested
- Chimeric Antigen Receptor T-cells (CAR-T) therapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric Antigen Receptor T-cells (CAR-T) therapyOther
Patients will be treated with CAR-T cell product as per routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DLBCL/HGBL and PMBCL | Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High-Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL) scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug Receives: Other: Chimeric Antigen Receptor T-cells (CAR-T) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessed neurocognitive performance
Self-assessed neurocognitive performance will be evaluated through Functional Assessment of Cancer Therapy - Cognitive questionnaire (FACT-Cog Version 3). The FACT-Cog (Version 3) is a self-report questionnaire developed within the measurement system of FACIT.org (Functional Assessment of Chronic Illness Therapy) to assess perceived cognitive functioning in individuals with cancer. The instrument includes 37 items in total, although the most commonly reported total score is based on 33 scored items. Each item is rated on a 5-point Likert scale (0-4) (0 = not at all; 4 = very much / very often, depending on the item). Total score (33-item scoring): Minimum: 0, Maximum: 132. Score interpretation: higher scores indicate better perceived cognitive functioning, lower scores indicate greater perceived cognitive impairment.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Neurocognitive performance evaluation: Cognitive Status - Mini-Mental State Examination (MMSE)
Cognitive status will be assessed using the Mini-Mental State Examination (MMSE).
Unit of Measure: Total score (points) Range: 0 to 30 Interpretation: Higher scores indicate better cognitive performance.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Quality of Life (QoL)
Quality of life will be evaluated through EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30). The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a 30-item instrument used to assess health-related quality of life in people with cancer.
All scales and single items are linearly transformed to a 0-100 scale (Minimum: 0 and Maximum: 100).
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Psychological status
Psychological status will be evaluated through HADS questionnaire (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale consists of two subscales: anxiety (HADS-A) and depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating worse psychological outcomes (greater anxiety or depression symptoms).
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Resilience
Resilience will be evaluated through RS-14 questionnaire (Resilience scale-14 questionnaire). The Resilience Scale-14 produces a total score ranging from 14 to 98, with higher scores indicating a better outcome (greater resilience).
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Adverse events
CRS (Cytokine Release Syndrome), ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) and IEC-HS (Immune Effector Cell associated HLH-like Syndrome) will be graded according to ASBMT (American Society for Blood and Marrow Transplantation ) consensus grading, ICAHT (Immune effector cell-associated hematotoxicity) will be graded according to EHA/EBMT (European Hematology Association/European Society for Blood and Marrow Transplantation) consensus grading, other extrahematological toxicities will be graded according to the latest version of CTCAE criteria (Common Terminology Criteria for Adverse Events).
Measured: The endpoint wil be evaluated at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Treatment characteristics: Previous Central Nervous System Prophylaxis
History of Central Nervous System prophylaxis prior to CAR-T therapy, including intrathecal methotrexate and/or high-dose methotrexate, collected from medical records. Unit of Measure: Participants with previous CNS prophylaxis (%).
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy)
Overall Survival (OS)
Overall Survival for all patients included in the study: defined as the time between the start of CAR-T until death from any cause.
Measured: The endpoint will be evaluated from the beginning to the end of the study (at least 24 months after CAR-T infusion)
Neurocognitive performance evaluation: Praxic Abilities - Rey-Osterrieth Complex Figure Test (Copy Condition)
Praxic and visuoconstructive abilities will be assessed using the copy condition of the Rey-Osterrieth Complex Figure Test (ROCF).
Unit of Measure: Total score (points) Range: 0 to 36 Interpretation: Higher scores indicate better praxic/visuoconstructive performance.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Neurocognitive performance evaluation: Verbal Memory - Rey Auditory Verbal Learning Test (Word List 3 Recall)
Verbal memory will be assessed using Word List 3 recall from the Rey Auditory Verbal Learning Test (RAVLT).
Unit of Measure: Number of words correctly recalled Range: 0 to 15 Interpretation: Higher scores indicate better verbal memory performance.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Neurocognitive performance evaluation: Visual Memory - Rey-Osterrieth Complex Figure Test (Delayed Recall)
Visual memory will be assessed using the delayed recall condition of the Rey-Osterrieth Complex Figure Test (ROCF).
Unit of Measure: Total score (points) Range: 0 to 36 Interpretation: Higher scores indicate better visual memory performance.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Neurocognitive performance evaluation: Language - Verbal Fluency Test
Language function will be assessed using a Verbal Fluency Test (phonemic and/or semantic, as applicable).
Unit of Measure: Number of correct words generated within the allotted time Range: No fixed maximum value Interpretation: Higher scores indicate better language performance.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Neurocognitive performance status: Attention and Processing Speed - Trail Making Test Part A
Attention and processing speed will be assessed using Part A of the Trail Making Test (TMT-A).
Unit of Measure: Completion time (seconds) Range: Continuous variable (no fixed maximum) Interpretation: Lower scores indicate better performance.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion).
Neurocognitive performance evaluation: Executive Function - Trail Making Test Part B.
Executive function will be assessed using Part B of the Trail Making Test (TMT-B).
Unit of Measure: Completion time (seconds) Range: Continuous variable (no fixed maximum) Interpretation: Lower scores indicate better performance.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Neurocognitive performance evaluation: Attention and Processing Speed - Symbol Digit Modalities Test (Oral Version)
Attention and processing speed will be assessed using the oral version of the Symbol Digit Modalities Test (SDMT).
Unit of Measure: Number of correct substitutions Range: No fixed maximum value (administration time-dependent) Interpretation: Higher scores indicate better attention and processing speed.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion).
Neurocognitive performance evaluation: Executive Function - Frontal Assessment Battery
Executive function will be assessed using the Frontal Assessment Battery (FAB). Unit of Measure: Total score (points) Range: 0 to 18 Interpretation: Higher scores indicate better executive functioning.
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion).
Treatment characteristics: Cumulative Anthracycline Dose
Total cumulative dose of anthracycline chemotherapy received prior to CAR-T therapy, collected from medical records.
Unit of Measure: Milligrams per square meter (mg/m²).
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy).
Treatment characteristics: Prior Radiotherapy Field
Anatomical field of radiotherapy received prior to CAR-T therapy as recorded in medical records (e.g., mediastinal, cranial, total body irradiation, or other).
Unit of Measure: Participants by radiotherapy field (%).
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy).
Treatment characteristics: Prior Radiotherapy Dose
Total radiation dose delivered during previous radiotherapy treatments before CAR-T therapy, obtained from medical records.
Unit of Measure: Gray (Gy).
Measured: The endpoint wil be evaluated at screening (before starting CAR-T therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Lorenzo Farinelli Onlus
- Responsible party
- Sponsor
- Investigators
- Luca Castagna, Principal investigator, A.O. Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463781
- Sponsor's protocol ID
- FIL_NEURO_CAR-T
- Acronym
- NEURO_CAR-T
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy: a Multicenter Observational Prospective Study
- ClinicalTrials.gov ID
- NCT07463781
- Acronym / sponsor ID
- NEURO_CAR-T / FIL_NEURO_CAR-T
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Collaborators
- Fondazione Lorenzo Farinelli Onlus
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. A longitudinal survey will be carried out by collecting patients' data before starting CAR-T (T0) and after 6 (T1), 12 (T2) and 24 (T3) months after CAR-T infusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DLBCL/HGBL and PMBCL | – | Other: Chimeric Antigen Receptor T-cells (CAR-T) therapyPatients with previous diagnosis of Diffuse Large B Cell Lymphoma or High-Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL) scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High-Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL) scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug
Key inclusion criteria (3 listed)
- Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High- Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL).
- Patients undergoing CD19-targeted CAR-T cell salvage therapy for relapsed/refractory disease according to AIFA inclusion criteria.
- Age over 18-years-old at the time of lymphoma diagnosis.
Key exclusion criteria (4 listed)
- Patient with histological diagnosis of mantle cell lymphoma (MCL) or acute lymphoblastic leukemia (ALL)
- Patients with CNS disease localization.
- Patients that received brain/neuroaxis radiotherapy.
- Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimeric Antigen Receptor T-cells (CAR-T) therapyPatients will be treated with CAR-T cell product as per routine clinical practice. | Other | Patients with DLBCL/HGBL and PMBCL |
Primary outcome
Self-assessed neurocognitive performance
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Self-assessed neurocognitive performance will be evaluated through Functional Assessment of Cancer Therapy - Cognitive questionnaire (FACT-Cog Version 3). The FACT-Cog (Version 3) is a self-report questionnaire developed within the measurement system of FACIT.org (Functional Assessment of Chronic Illness Therapy) to assess perceived cognitive functioning in individuals with cancer. The instrument includes 37 items in total, although the most commonly reported total score is based on 33 scored items. Each item is rated on a 5-point Likert scale (0-4) (0 = not at all; 4 = very much / very often, depending on the item). Total score (33-item scoring): Minimum: 0, Maximum: 132. Score interpretation: higher scores indicate better perceived cognitive functioning, lower scores indicate greater perceived cognitive impairment.
Neurocognitive performance evaluation: Cognitive Status - Mini-Mental State Examination (MMSE)
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Cognitive status will be assessed using the Mini-Mental State Examination (MMSE). Unit of Measure: Total score (points) Range: 0 to 30 Interpretation: Higher scores indicate better cognitive performance.
Quality of Life (QoL)
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Quality of life will be evaluated through EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30). The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a 30-item instrument used to assess health-related quality of life in people with cancer. All scales and single items are linearly transformed to a 0-100 scale (Minimum: 0 and Maximum: 100).
Psychological status
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Psychological status will be evaluated through HADS questionnaire (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale consists of two subscales: anxiety (HADS-A) and depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating worse psychological outcomes (greater anxiety or depression symptoms).
Resilience
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Resilience will be evaluated through RS-14 questionnaire (Resilience scale-14 questionnaire). The Resilience Scale-14 produces a total score ranging from 14 to 98, with higher scores indicating a better outcome (greater resilience).
Adverse events
Time frame: The endpoint wil be evaluated at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
CRS (Cytokine Release Syndrome), ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) and IEC-HS (Immune Effector Cell associated HLH-like Syndrome) will be graded according to ASBMT (American Society for Blood and Marrow Transplantation ) consensus grading, ICAHT (Immune effector cell-associated hematotoxicity) will be graded according to EHA/EBMT (European Hematology Association/European Society for Blood and Marrow Transplantation) consensus grading, other extrahematological toxicities will be graded according to the latest version of CTCAE criteria (Common Terminology Criteria for Adverse Events).
Treatment characteristics: Previous Central Nervous System Prophylaxis
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy)
History of Central Nervous System prophylaxis prior to CAR-T therapy, including intrathecal methotrexate and/or high-dose methotrexate, collected from medical records. Unit of Measure: Participants with previous CNS prophylaxis (%).
Overall Survival (OS)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (at least 24 months after CAR-T infusion)
Overall Survival for all patients included in the study: defined as the time between the start of CAR-T until death from any cause.
Neurocognitive performance evaluation: Praxic Abilities - Rey-Osterrieth Complex Figure Test (Copy Condition)
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Praxic and visuoconstructive abilities will be assessed using the copy condition of the Rey-Osterrieth Complex Figure Test (ROCF). Unit of Measure: Total score (points) Range: 0 to 36 Interpretation: Higher scores indicate better praxic/visuoconstructive performance.
Neurocognitive performance evaluation: Verbal Memory - Rey Auditory Verbal Learning Test (Word List 3 Recall)
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Verbal memory will be assessed using Word List 3 recall from the Rey Auditory Verbal Learning Test (RAVLT). Unit of Measure: Number of words correctly recalled Range: 0 to 15 Interpretation: Higher scores indicate better verbal memory performance.
Neurocognitive performance evaluation: Visual Memory - Rey-Osterrieth Complex Figure Test (Delayed Recall)
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Visual memory will be assessed using the delayed recall condition of the Rey-Osterrieth Complex Figure Test (ROCF). Unit of Measure: Total score (points) Range: 0 to 36 Interpretation: Higher scores indicate better visual memory performance.
Neurocognitive performance evaluation: Language - Verbal Fluency Test
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Language function will be assessed using a Verbal Fluency Test (phonemic and/or semantic, as applicable). Unit of Measure: Number of correct words generated within the allotted time Range: No fixed maximum value Interpretation: Higher scores indicate better language performance.
Neurocognitive performance status: Attention and Processing Speed - Trail Making Test Part A
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion).
Attention and processing speed will be assessed using Part A of the Trail Making Test (TMT-A). Unit of Measure: Completion time (seconds) Range: Continuous variable (no fixed maximum) Interpretation: Lower scores indicate better performance.
Neurocognitive performance evaluation: Executive Function - Trail Making Test Part B.
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)
Executive function will be assessed using Part B of the Trail Making Test (TMT-B). Unit of Measure: Completion time (seconds) Range: Continuous variable (no fixed maximum) Interpretation: Lower scores indicate better performance.
Neurocognitive performance evaluation: Attention and Processing Speed - Symbol Digit Modalities Test (Oral Version)
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion).
Attention and processing speed will be assessed using the oral version of the Symbol Digit Modalities Test (SDMT). Unit of Measure: Number of correct substitutions Range: No fixed maximum value (administration time-dependent) Interpretation: Higher scores indicate better attention and processing speed.
Neurocognitive performance evaluation: Executive Function - Frontal Assessment Battery
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion).
Executive function will be assessed using the Frontal Assessment Battery (FAB). Unit of Measure: Total score (points) Range: 0 to 18 Interpretation: Higher scores indicate better executive functioning.
Treatment characteristics: Cumulative Anthracycline Dose
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy).
Total cumulative dose of anthracycline chemotherapy received prior to CAR-T therapy, collected from medical records. Unit of Measure: Milligrams per square meter (mg/m²).
Treatment characteristics: Prior Radiotherapy Field
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy).
Anatomical field of radiotherapy received prior to CAR-T therapy as recorded in medical records (e.g., mediastinal, cranial, total body irradiation, or other). Unit of Measure: Participants by radiotherapy field (%).
Treatment characteristics: Prior Radiotherapy Dose
Time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy).
Total radiation dose delivered during previous radiotherapy treatments before CAR-T therapy, obtained from medical records. Unit of Measure: Gray (Gy).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Castagna principal investigator
A.O. Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma (DLBCL) and High Grade B Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessed neurocognitive performance (time frame: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.