Classic Hodgkin LymphomaFIL_LymDeCoNCT07652476
Neurocognitive Assessment in Long-Term Survivors of Lymphoma
An observational study of Classic Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), run by Fondazione Italiana Linfomi - ETS at 7 sites in Italy.
Trial summary
This is an observational, multicenter, prospective cohort study including patients treated for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Classic Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B Cell Lymphoma
- What is being tested?
- anthracycline containing regimen
- How many people
- 100 participants
- Where
- 7 sitesItaly
- Study dates
- Sep 2026to Mar 2028
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL) in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.
Who may be able to join
- Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).
- Patients in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.
- Age ≥ 25 and ≤ 55 at enrollment.
- Patients between third and fifth year of follow-up after the end of the first line treatment.
- Absence of signs or symptoms of disease relapse.
Who cannot join
- 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
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites
Clinica di Ematologia, AOU Ospedali Riuniti
Ancona
Guido Gini, +390715964562, guido.gini@ospedaliriuniti.marche.it
Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
Aviano
Rosanna Ciancia, +390434659645, rciancia@cro.it
U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari
Carla Minoia, +390805555414, carla.minoia1@gmail.com
U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese
Legnano
Silvia Franceschetti, +393333456770, silvia.franceschetti@asst-ovestmi.it
Ematologia - Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
Milan
Francesca Gaia Rossi, +390255033466, francescagaia.rossi@policlinico.mi.it
SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan
Erika Meli, +390264442668, erika.meli@ospedaleniguarda.it
Ematologia - AOU Policlinico Giaccone
Palermo
Salvatrice Mancuso, +390916554505, salvatrice.mancuso@unipa.it
About this study
Official title: Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)
This is an observational, multicenter, prospective cohort study including patients treated for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Patients will be evaluated once during regular follow-up, in the absence of clinical or radiologic signs of disease relapse.
The assessment of neurocognitive functioning will be performed through a panel of tests, both self-administered and individually administered (about 1 hour). The administration of these neuropsychological tests should be done according to a standardized and predefined order. If available, according to local practice, a neuropsychologist may be involved in test administration and in the evaluation of the results.
Based on its observational nature, no treatment change or modification or additional exams or visits will be required because of being enrolled in this study.
- Conditions
- Classic Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B Cell Lymphoma
- Being tested
- anthracycline containing regimen
- 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.
anthracycline containing regimenDrug
Patients in complete remission after treatment with first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma | Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL) in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.
Patients between third and fifth year of follow-up after the end of the first line treatment. Receives: Drug: anthracycline containing regimen |
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive performance evaluation: Language - Verbal Fluency Test (Phonemic and semanthic)
Language function will be assessed using a Verbal Fluency Test (phonemic and semantic). 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 will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive performance evaluation: Language - Naming of colored Photographs
Language function assessed through a picture-naming task in which participants are asked to correctly name colored photographs depicting common objects, people, or scenes. Performance is evaluated based on the accuracy of responses, reflecting lexical retrieval, semantic processing, and expressive language abilities. Higher scores indicate better language performance.
Measured: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive performance evaluation: Verbal Memory - Digit Span Test (Forward, Backward)
Verbal memory and working memory assessed using the Digit Span Test. Participants are required to recall and repeat sequences of digits in the same order (Forward Digit Span) and in reverse order (Backward Digit Span). Performance is evaluated based on the number of correctly recalled sequences and/or total score achieved, reflecting attention, short-term verbal memory, and working memory capacity. Higher scores indicate better cognitive performance.
Measured: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive performance evaluation: Visual-spatial memory/praxic-constructive functions - Corsi Span Test (Forward, Backward)
Visual-spatial short-term memory and working memory assessed using the Corsi Span Test. Participants are required to reproduce sequences of spatial locations in the same order (Forward Corsi Span) and in reverse order (Backward Corsi Span). Performance is evaluated based on the number of correctly reproduced sequences and/or span length achieved, reflecting visual-spatial memory, spatial working memory, and praxic-constructive abilities. Higher scores indicate better cognitive performance.
Measured: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive performance evaluation: Visual-spatial memory/praxic-constructive functions - Rey-Osterrieth Complex Figure Test (ROCF)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive performance status: Executive and attentive functions - Trail Making Test (TMT) Part A and B
Executive and attentive functions will be assessed using Part A and B of the Trail Making Test (TMT). Unit of Measure: Completion time (seconds) Range: Continuous variable (no fixed maximum) Interpretation: Lower scores indicate better performance.
Measured: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive performance evaluation: Executive and attentive functions - Symbol Digit Modalities Test (SDTM) - Oral Version
Executive and attentive functions 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 will be evaluated only once after screening and signing of informed consent form (Day 1)
Neurocognitive Performance Evaluation: Executive and Attentive Functions - Stroop Color-Word Test (Short Version)
Executive and attentional functioning assessed using the short version of the Stroop Color-Word Test. Participants are required to identify the color of printed stimuli while inhibiting automatic reading responses. Performance is evaluated based on completion time, number of correct responses, and/or errors made during the task, reflecting selective attention, cognitive flexibility, processing speed, and inhibitory control. Better performance is indicated by faster completion times and fewer errors.
Measured: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
Treatment characteristics: Anthracycline Cumulative 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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Hodgkin LymphomaStudies 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
- Associazione Italiana contro Leucemie, Linfomi e Mieloma
- Responsible party
- Sponsor
- Investigators
- Silvia Franceschetti, Principal investigator, U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese - Legnano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652476
- Sponsor's protocol ID
- FIL_LymDeCo
- Acronym
- FIL_LymDeCo
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)
- ClinicalTrials.gov ID
- NCT07652476
- Acronym / sponsor ID
- FIL_LymDeCo / FIL_LymDeCo
- Conditions
- Classic Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Collaborators
- Associazione Italiana contro Leucemie, Linfomi e Mieloma
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Jun 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 for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Patients will be evaluated once during regular follow-up, in the absence of clinical or radiologic signs of disease relapse.
The assessment of neurocognitive functioning will be performed through a panel of tests, both self-administered and individually administered (about 1 hour). The administration of these neuropsychological tests should be done according to a standardized and predefined order. If available, according to local practice, a neuropsychologist may be involved in test administration and in the evaluation of the results.
Based on its observational nature, no treatment change or modification or additional exams or visits will be required because of being enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma | – | Drug: anthracycline containing regimenPatients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL) in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy. Patients between third and fifth year of follow-up after the end of the first line treatment. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL) in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.
Key inclusion criteria (5 listed)
- Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).
- Patients in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy.
- Age ≥ 25 and ≤ 55 at enrollment.
- Patients between third and fifth year of follow-up after the end of the first line treatment.
- Absence of signs or symptoms of disease relapse.
Key exclusion criteria (3 listed)
- 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 |
|---|---|---|
| anthracycline containing regimenPatients in complete remission after treatment with first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +/- radiotherapy. | Drug | Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma |
Primary outcome
Self-assessed neurocognitive performance
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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.
Neurocognitive performance evaluation: Language - Verbal Fluency Test (Phonemic and semanthic)
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Language function will be assessed using a Verbal Fluency Test (phonemic and semantic). 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 evaluation: Language - Naming of colored Photographs
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Language function assessed through a picture-naming task in which participants are asked to correctly name colored photographs depicting common objects, people, or scenes. Performance is evaluated based on the accuracy of responses, reflecting lexical retrieval, semantic processing, and expressive language abilities. Higher scores indicate better language performance.
Neurocognitive performance evaluation: Verbal Memory - Digit Span Test (Forward, Backward)
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Verbal memory and working memory assessed using the Digit Span Test. Participants are required to recall and repeat sequences of digits in the same order (Forward Digit Span) and in reverse order (Backward Digit Span). Performance is evaluated based on the number of correctly recalled sequences and/or total score achieved, reflecting attention, short-term verbal memory, and working memory capacity. Higher scores indicate better cognitive performance.
Neurocognitive performance evaluation: Verbal Memory - Rey Auditory Verbal Learning Test (Word List 3 Recall)
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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-spatial memory/praxic-constructive functions - Corsi Span Test (Forward, Backward)
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Visual-spatial short-term memory and working memory assessed using the Corsi Span Test. Participants are required to reproduce sequences of spatial locations in the same order (Forward Corsi Span) and in reverse order (Backward Corsi Span). Performance is evaluated based on the number of correctly reproduced sequences and/or span length achieved, reflecting visual-spatial memory, spatial working memory, and praxic-constructive abilities. Higher scores indicate better cognitive performance.
Neurocognitive performance evaluation: Visual-spatial memory/praxic-constructive functions - Rey-Osterrieth Complex Figure Test (ROCF)
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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 status: Executive and attentive functions - Trail Making Test (TMT) Part A and B
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Executive and attentive functions will be assessed using Part A and B of the Trail Making Test (TMT). Unit of Measure: Completion time (seconds) Range: Continuous variable (no fixed maximum) Interpretation: Lower scores indicate better performance.
Neurocognitive performance evaluation: Executive and attentive functions - Symbol Digit Modalities Test (SDTM) - Oral Version
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Executive and attentive functions 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 and Attentive Functions - Stroop Color-Word Test (Short Version)
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
Executive and attentional functioning assessed using the short version of the Stroop Color-Word Test. Participants are required to identify the color of printed stimuli while inhibiting automatic reading responses. Performance is evaluated based on completion time, number of correct responses, and/or errors made during the task, reflecting selective attention, cognitive flexibility, processing speed, and inhibitory control. Better performance is indicated by faster completion times and fewer errors.
Quality of Life (QoL)
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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).
Treatment characteristics: Previous Central Nervous System Prophylaxis
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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 (%).
Treatment characteristics: Anthracycline Cumulative Dose
Time frame: The endpoint will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 will be evaluated only once after screening and signing of informed consent form (Day 1)
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 22 Jun 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.
Silvia Franceschetti principal investigator
U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese - Legnano
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Classic Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), run by Fondazione Italiana Linfomi - ETS at 7 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 5 inclusion and 3 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Iolanda 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 will be evaluated only once after screening and signing of informed consent form (Day 1)). The study lists 18 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 22 Jun 2026.