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Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy

Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04985214
Acronym
EVEREST
Enrollment
464
Registered
2021-08-02
Start date
2020-05-14
Completion date
2025-01-01
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

oral therapy, lymphoma, quality of life

Brief summary

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).

Detailed description

Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.

Interventions

OTHERQuestionnaire

Questionnaire on the quality of life

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients included in the PK-E3i clinical study OR * Over the age of 18 * Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib…) * Be able to understand the objective and the constraints related to research * Patient having read the information notice and the non-objection form * Social Security affiliation

Exclusion criteria

* Pregnant women * Persons under legal protection of adults * Patients under judicial protection

Design outcomes

Primary

MeasureTime frameDescription
Quality of life measurement5 yearsEvaluation of the quality of life score, throught the quality of life scale (higher score associated with poor quality of life)

Secondary

MeasureTime frameDescription
Evaluation of patients factors5 yearsCollect of clinical and socio-professional characteristics of the patient

Countries

France

Contacts

Primary ContactLoïc YSEBAERT, Prof.
ysebaert.loic@iuct-oncopole.fr0531156351
Backup ContactFabien DESPAS, MD
fabien.despas@univ-tlse3.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026