Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05524298

Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Local histological diagnosis of indolent B cell non-Hodgkin lymphoma: follicular lymphoma, marginal zone lymphoma (nodal, MALT (Mucosa-Associated Lymphoid Tissue), splenic), lymphoplasmacytic lymphoma/ Waldenström macroglobulinemia)
  • Age ≥ 70 years
  • Patient candidates to receive treatment for lymphoma
  • Patient previously untreated for lymphoma
  • Evaluation of Comprehensive Geriatric Assessment at baseline
  • Ability to provide informed consent: subject understands and voluntarily signs an informed consent form approved by an IEC (Independent Ethics Committee), prior to registration into the study

Note: Patient treated in the context of a clinical trial is admitted

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. QoL (quality of life) scores at baseline - EORTC-QLQ-C30

    Time frame: The endpoint wil be evaluated at the baseline.

    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)

  2. QoL (quality of life) scores variations at the end of treatment - EORTC-QLQ-C30

    Time frame: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)

    Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30)

  3. QoL (quality of life) scores variations after 1 year from the start of therapy - EORTC-QLQ-C30

    Time frame: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)

    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)

  4. QoL (quality of life) scores at baseline - FACT-Lym-LymS

    Time frame: The endpoint wil be evaluated at the baseline.

    Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms)

  5. QoL (quality of life) scores variations at the end of treatment - FACT-Lym-LymS

    Time frame: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)

    Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)

  6. QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS

    Time frame: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)

    Quality of life is measured with FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)

    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.

  2. Progression-Free Survival (PFS)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)

    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.

  3. Event-Free Survival (EFS)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)

    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.

  4. Overall Response Rate (ORR)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)

    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.

  5. Registration of safety

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Iolanda De Martino

CONTACT

[email protected]

+39 0131 033153

Marina Cesaretti

CONTACT

[email protected]

+39 059 9769913

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study title

Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.