Low Grade Non-Hodgkin's Lymphoma, AdultNCT05524298
Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma
An observational study of Low Grade Non-Hodgkin's Lymphoma, Adult, run by Fondazione Italiana Linfomi - ETS at 21 sites in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Low Grade Non-Hodgkin's Lymphoma, Adult
- How many people
- 150 participants
- Where
- 21 sitesItaly
- Study dates
- 7 Dec 2022to Dec 2026
- Phase
- Observational
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Italy21 sites, 21 recruiting
- Recruiting
S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Alessandria, 15121
Manuela Zanni, MD, manuela.zanni@ospedale.al.it
Manuela Zanni
- Recruiting
Clinica di Ematologia - A.O.U. Ospedali Riuniti
Ancona, Italy, 60126
Guido Gini, MD, guido.gini@ospedaliriuniti.marche.it
Gini Guido
- Recruiting
Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, 33081
Michele Spina, MD, mspina@cro.it
Michele Spina
- Recruiting
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Carla Minoia, MD, carlaminoia@libero.it
Carla Minoia
- Recruiting
Ospedale San Bassiano - AULSS7 Pedemontana - UOC Oncoematologia
Bassano del Grappa, Vicenza, 36061
Valerio Guarente, MD, valerio.guarente@aulss7.veneto.it
Gloria Martignano, gloria.martignago@aulss7.veneto.it
- Recruiting
Ematologia - ASST Spedali Civili di Brescia
Brescia, Italy, 25123
Alessandra Tucci, MD, alessandra.tucci@asst-spedalicivili.it
Alessandra Tucci
- Recruiting
Ematologia - Ospedale di Castelfranco Veneto
Castelfranco Veneto, Italy, 31033
Nilla Maschio, MD, nilla.maschio@iov.veneto.it
Roberto Sartori
- Recruiting
U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco
Catania, Italy, 95123
Annalisa Chiarenza, MD
Annalisa Chiarenza
- Recruiting
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50141
Benedetta Puccini, MD, puccinib@aou-careggi.toscana.it
Benedetta Puccini
- Not yet recruiting
S.C. Ematologia - Azienda Ospedali Riuniti Papardo-Piemonte
Messina, Italy, 98158
Donato Mannina, MD, donamanni@gmail.com
Donato Mannina
- Recruiting
Unitа Linfomi - Dipartimento Oncoematologia, Istituto Scientifico San Raffaele
Milan, Italy, 20132
Andrés Ferreri, MD, andres.ferreri@hsr.it
Andrés Ferreri
- Recruiting
S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Cristina Muzi, MD, cristina.muzi@ospedaleniguarda.it
Cristina Muzi
- Recruiting
Ematologia - A.O.U. Policlinico Giaccone
Palermo, Italy, 90127
Salvatrice Mancuso, MD, salvatrice.mancuso@unipa.it
Salvatrice Mancuso
- Recruiting
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy, 90146
Caterina Patti, MD, k.patti@villasofia.it
Caterina Patti
- Recruiting
U.O. Ematologia - Ospedale Guglielmo da Saliceto
Piacenza, Italy, 29121
Annalisa Arcari, MD, a.arcari@ausl.pc.it
Annalisa Arcari
- Recruiting
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42123
Stefano Luminari, MD, stefano.luminari@ausl.re.it
Maria Elena Nizzoli
- Recruiting
U.O. di Ematologia - Ospedale degli Infermi di Rimini
Rimini, Italy, 47923
Melania Celli, MD, melania.celli@auslromagna.it
Melania Celli
- Recruiting
Ematologia,Trapianto cellule staminali, Medicina Trasfusionale e Terapia cellulare -Policlinico Universitario Campus Bio-Medico
Roma, Italy, 00128
Ombretta Annibali, MD, o.annibali@policlinicocampus.it
Ombretta Annibali
- Recruiting
U.O.C. Ematologia - A.O.U. Senese
Siena, Italy, 53100
Alberto Fabbri, MD, fabbri7@unisi.it
Alberto Fabbri
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino
Federica Cavallo, MD, f.cavallo@unito.it
Federica Cavallo, f.cavallo@unito.it
- Recruiting
U.O.C. Ematologia - Ospedale di Circolo
Varese, Italy, 21100
Michele Merli, MD, michele.merli@asst-settelaghi.it
Michele Merli
About this study
Official 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
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).
Read the detailed description
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).
- Conditions
- Low Grade Non-Hodgkin's Lymphoma, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Patients With Low Grade Non-Hodgkin Lymphoma | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start7 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Non-Hodgkin's Lymphoma, AdultStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salvatrice Mancuso, Principal investigator, Ematologia - A.O.U. Policlinico Giaccone, Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524298
- Sponsor's protocol ID
- FIL_QoL-ELDIND
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No