An observational study in Low Grade Non-Hodgkin's Lymphoma, Adult, sponsored by Fondazione Italiana Linfomi - ETS. Recruiting at 21 sites in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Fondazione Italiana Linfomi - ETS · Observational
Aims of this study are to describe the variation of QoL (Quality of Life) during the clinical management of low-grade lymphoma in elderly subjects and to identify the most important factors at diagnosis and during treatment with an impact on QoL (Quality of Life).
This is a prospective, multicenter, non-interventional study aiming at investigating on the changes in QoL (Quality of Life) during the clinical management of low-grade lymphoma in elderly subjects and to possibly identify the most important factors at diagnosis and during treatment with an impact on QoL (Quality of Life).
The study plans to enroll 150 patients with a local histologically confirmed diagnosis of indolent non-Hodgkin lymphoma fulfilling all the inclusion/exclusion criteria who provide written informed consent will be included in the study. Any type of treatment is allowed by the study (immunotherapy, immunochemotherapy at full or reduced dose, radiotherapy).
All patients must undergo Comprehensive Geriatric Assessment (CGA) before starting any protocol treatment.
Baseline, post-treatment and follow-up instrumental assessments and response evaluation is done as part of the routine clinical management for patients with indolent NHL (Non Hodgkin Lymphoma) . Response evaluation and all other assessments planned for the EOT (end of treatment) should be planned also in case of early withdrawal, according to clinical practice.
HRQoL (Health-related Quality of Life) evaluation will be done at time of informed consent form signature prior to treatment start, at the end of the treatment (ranging from 1 month to 6 months according to the duration of the treatment) and after 1 year from the start of the therapy.
QoL (quality of life) assessment includes all scales of the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire-Core 30) and the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma - lymphoma-specific symptoms questionnaire).
Fondazione Italiana Linfomi - ETS is the lead sponsor of 91 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: Patient treated in the context of a clinical trial is admitted
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy. Assess QoL (quality of life) at baseline, at the end of treatment and after 1 year from the start of the therapy.
QoL (quality of life) scores at baseline - EORTC-QLQ-C30
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) questionnaire)
Time frame: The endpoint wil be evaluated at the baseline.
QoL (quality of life) scores variations at the end of treatment - EORTC-QLQ-C30
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30)
Time frame: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)
QoL (quality of life) scores variations after 1 year from the start of therapy - EORTC-QLQ-C30
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) and FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
Time frame: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)
QoL (quality of life) scores at baseline - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms)
Time frame: The endpoint wil be evaluated at the baseline.
QoL (quality of life) scores variations at the end of treatment - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
Time frame: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)
QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS
Quality of life is measured with FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
Time frame: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)
Overall Survival (OS)
Overall survival, the percentage of patients alive, is defined as the time between the date of registration and the date of death from any cause.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
Progression-Free Survival (PFS)
Progression-Free Survival is defined as the time between the date of registration and the date of disease progression, relapse or death from any cause.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
Event-Free Survival (EFS)
Event-Free Survival is defined as the time from start of treatment to disease progression, death or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without document progression.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
Overall Response Rate (ORR)
Overall response rate is defined as the proportion of patients who have a complete response (CR), or partial response (PR) or stable disease (SD) to therapy.Overall Response Rate (ORR) will be defined according to the Lugano 2014 criteria.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
Registration of safety
Safety is defined as incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), current version.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
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Fondazione Italiana Linfomi - ETS