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ClinicalTrials.gov ID

NCT07652476

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Jun 22, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Mar 2028Estimated

Official Title

Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)

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.

• Classic Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma (DLBCL)
• Primary Mediastinal B Cell Lymphoma

• anthracycline containing regimen

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

Collaborators

Associazione Italiana contro Leucemie, Linfomi e MielomaUNKNOWN

salvatrice.mancuso@unipa.it+390916554505