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

NCT05524298 | Recruiting

• 1 other identifier: FIL_QoL-ELDIND
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 20

Brief 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).

Conditions

Low Grade Non-Hodgkin's Lymphoma, Adult

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  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)

  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)

  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)

  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)

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

Secondary Outcomes (5)

• Overall Survival (OS)

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

• Progression-Free Survival (PFS)

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

• Event-Free Survival (EFS)

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

• Overall Response Rate (ORR)

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

• Registration of safety

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (20)

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

Alessandria, Alessandria, 15121, Italy

RECRUITING

Clinica di Ematologia - A.O.U. Ospedali Riuniti

Ancona, Italy, 60126, Italy

RECRUITING

U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II

Bari, Italy, 70124, Italy

RECRUITING

Ematologia - ASST Spedali Civili di Brescia

Brescia, Italy, 25123, Italy

RECRUITING

Ematologia - Ospedale di Castelfranco Veneto

Castelfranco Veneto, Italy, 31033, Italy

RECRUITING

U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco

Catania, Italy, 95123, Italy

RECRUITING

Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi

Florence, Italy, 50141, Italy

RECRUITING

S.C. Ematologia - Azienda Ospedali Riuniti Papardo-Piemonte

Messina, Italy, 98158, Italy

RECRUITING

Unitа Linfomi - Dipartimento Oncoematologia, Istituto Scientifico San Raffaele

Milan, Italy, 20132, Italy

RECRUITING

S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162, Italy

RECRUITING

Ematologia - A.O.U. Policlinico Giaccone

Palermo, Italy, 90127, Italy

RECRUITING

Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello

Palermo, Italy, 90146, Italy

RECRUITING

U.O. Ematologia - Ospedale Guglielmo da Saliceto

Piacenza, Italy, 29121, Italy

RECRUITING

Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42123, Italy

RECRUITING

U.O. di Ematologia - Ospedale degli Infermi di Rimini

Rimini, Italy, 47923, Italy

RECRUITING

Ematologia,Trapianto cellule staminali, Medicina Trasfusionale e Terapia cellulare -Policlinico Universitario Campus Bio-Medico

Roma, Italy, 00128, Italy

RECRUITING

U.O.C. Ematologia - A.O.U. Senese

Siena, Italy, 53100, Italy

RECRUITING

U.O.C. Ematologia - Ospedale di Circolo

Varese, Italy, 21100, Italy

RECRUITING

Ospedale San Bassiano - AULSS7 Pedemontana - UOC Oncoematologia

Bassano del Grappa, Vicenza, 36061, Italy

RECRUITING

Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano

Aviano, 33081, Italy

RECRUITING

Study Officials

• Salvatrice Mancuso

  Ematologia - A.O.U. Policlinico Giaccone, Palermo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Cesaretti

CONTACT

+39 059 9769913; mcesaretti@filinf.it

Iolanda De Martino

CONTACT

+39 0131 033153; idemartino@filinf.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: September 1, 2022
• Study Start: December 7, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

IT (20)