An observational study in Quality of Life, sponsored by University Hospital, Toulouse. Recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by University Hospital, Toulouse · Observational
The emergence of new anti-cancer drugs orally administered has revolutionized the prognosis and modalities of management of several lymphomas over the past decade. Today, half of patients receive oral therapy at home. Ibrutinib, acalabrutinib, idelalisib, venetoclax and lenalidomide are oral therapies used in the treatment of Chronic Lymphoid Leukemia, Follicular Lymphoma, Waldenström's disease and mantle cell lymphoma, in relapsing but soon to be 1st line.
Nevertheless, clinical trials leading to marketing authorizations for these drugs were performed in a small number of patients and very little data is available on their use in real life conditions. Their impact on the quality of life of patients also remains to be assessed.
The aim of this clinical research is to evaluate quality of life of patients at the initiation of the first oral therapy and every year for 5 years. This study will also identify factors (biological and non-biological: quality of life, shared decision-making ...) associated with a good response of patients and follow-up for the occurrence of long-term adverse reactions (5 years).
Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 464 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib...)
Exclusion Criteria:
Patients included in the PK-E3i clinical study or patients with hemopathies starting treatment with oral therapy.
Other: Questionnaire
Questionnaire on the quality of life
Quality of life measurement
Evaluation of the quality of life score, throught the quality of life scale (higher score associated with poor quality of life)
Time frame: 5 years
Evaluation of patients factors
Collect of clinical and socio-professional characteristics of the patient
Time frame: 5 years
Plan to share: No
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University Hospital, Toulouse