Classic Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B Cell Lymphoma
Conditions
Brief 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. 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.
Interventions
DRUGanthracycline containing regimen
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.
Sponsors
Fondazione Italiana Linfomi - ETS
Associazione Italiana contro Leucemie, Linfomi e Mieloma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with CNS disease localization. * Patients that received brain/neuroaxis radiotherapy. * Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-assessed neurocognitive performance | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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). |
Countries
Italy
Contacts
CONTACTIolanda Uffici Studi FIL
CONTACTUffici Studi FIL
PRINCIPAL_INVESTIGATORSilvia Franceschetti
U.O.C. Ematologia Ospedale Civile di Legnano - ASST Ovest Milanese - Legnano
Outcome results
None listed