Low Grade Non-Hodgkin's Lymphoma, Adult
Conditions
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).
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).
Interventions
None listed
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoL (quality of life) scores at baseline - EORTC-QLQ-C30 | 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) |
| QoL (quality of life) scores variations at the end of treatment - EORTC-QLQ-C30 | 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) |
| QoL (quality of life) scores variations after 1 year from the start of therapy - EORTC-QLQ-C30 | 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) |
| QoL (quality of life) scores at baseline - FACT-Lym-LymS | 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) |
| QoL (quality of life) scores variations at the end of treatment - FACT-Lym-LymS | 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) |
| QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Progression-Free Survival (PFS) | 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. |
| Event-Free Survival (EFS) | 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. |
| Overall Response Rate (ORR) | 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. |
| Registration of safety | 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. |
Countries
Italy
Contacts
CONTACTMarina Cesaretti
CONTACTIolanda De Martino
PRINCIPAL_INVESTIGATORSalvatrice Mancuso
Ematologia - A.O.U. Policlinico Giaccone, Palermo
Outcome results
None listed