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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The endpoint will be evaluated from the beginning to the end of the study (up to 30 months) |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Note: Patient treated in the context of a clinical trial is admitted
Exclusion Criteria:
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Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Cesaretti | Contact | +39 059 9769913 | mcesaretti@filinf.it | |
| Iolanda De Martino | Contact | +39 0131 033153 | idemartino@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Salvatrice Mancuso | Ematologia - A.O.U. Policlinico Giaccone, Palermo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo | Recruiting | Alessandria | Alessandria | 15121 | Italy |
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| 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) |
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. |
| 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. | 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. | 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. | The endpoint will be evaluated from the beginning to the end of the study (up to 30 months) |
| Clinica di Ematologia - A.O.U. Ospedali Riuniti | Recruiting | Ancona | Italy | 60126 | Italy |
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| U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II | Recruiting | Bari | Italy | 70124 | Italy |
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| Ematologia - ASST Spedali Civili di Brescia | Recruiting | Brescia | Italy | 25123 | Italy |
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| Ematologia - Ospedale di Castelfranco Veneto | Recruiting | Castelfranco Veneto | Italy | 31033 | Italy |
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| U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco | Recruiting | Catania | Italy | 95123 | Italy |
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| Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi | Recruiting | Florence | Italy | 50141 | Italy |
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| S.C. Ematologia - Azienda Ospedali Riuniti Papardo-Piemonte | Recruiting | Messina | Italy | 98158 | Italy |
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| Unitа Linfomi - Dipartimento Oncoematologia, Istituto Scientifico San Raffaele | Recruiting | Milan | Italy | 20132 | Italy |
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| S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Italy | 20162 | Italy |
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| Ematologia - A.O.U. Policlinico Giaccone | Recruiting | Palermo | Italy | 90127 | Italy |
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| Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello | Recruiting | Palermo | Italy | 90146 | Italy |
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| U.O. Ematologia - Ospedale Guglielmo da Saliceto | Recruiting | Piacenza | Italy | 29121 | Italy |
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| Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova | Recruiting | Reggio Emilia | Italy | 42123 | Italy |
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| U.O. di Ematologia - Ospedale degli Infermi di Rimini | Recruiting | Rimini | Italy | 47923 | Italy |
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| Ematologia,Trapianto cellule staminali, Medicina Trasfusionale e Terapia cellulare -Policlinico Universitario Campus Bio-Medico | Recruiting | Roma | Italy | 00128 | Italy |
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| U.O.C. Ematologia - A.O.U. Senese | Recruiting | Siena | Italy | 53100 | Italy |
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| U.O.C. Ematologia - Ospedale di Circolo | Recruiting | Varese | Italy | 21100 | Italy |
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| Ospedale San Bassiano - AULSS7 Pedemontana - UOC Oncoematologia | Recruiting | Bassano del Grappa | Vicenza | 36061 | Italy |
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| Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano | Recruiting | Aviano | 33081 | Italy |
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