Epcoritamab and Rituximab for First-line Follicular Lymphoma
NCT05783609
Follicular Lymphoma, Hemic and Lymphatic Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT05524298
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).
Interested in participating?
Request Info70 year and older
All sexes
Observational
S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Note: Patient treated in the context of a clinical trial is admitted
Exclusion criteria
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Iolanda De Martino
CONTACT
Marina Cesaretti
CONTACT
Fondazione Italiana Linfomi - ETS
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05783609
Follicular Lymphoma, Hemic and Lymphatic Diseases
Boston, Massachusetts, United States
View Trial Details