Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorFondazione Italiana Linfomi - ETS
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
none
Trial population
Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Elderly Patients With Low Grade Non-Hodgkin Lymphoma
Trial outcomes
Primary outcomes
1
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)
Time frame
The endpoint wil be evaluated at the baseline.2
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)
Time frame
The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)3
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)
Time frame
The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)4
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)
Time frame
The endpoint wil be evaluated at the baseline.Secondary outcomes
1
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.
Time frame
The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)2
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.
Time frame
The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)3
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.
Time frame
The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)4
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.
Time frame
The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)Sponsors and contacts
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Source ClinicalTrials.gov