Clinical trial NCT04985214: Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy
Official title: Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Keywords: oral therapy
lymphoma
quality of life
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib...)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life measurement
timeFrame: 5 years
Secondary outcomes:
measure: Evaluation of patients factors
timeFrame: 5 years
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH de Bayonne
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Chesnay
country: France
facility: CH Versailles
city: Le Mans
country: France
facility: CH Le Mans
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nîmes
city: Perpignan
country: France
facility: CH de Perpignan
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
city: Toulouse 9
country: France
facility: Loïc YSEBAERT
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: University Hospital, Toulouse
name: Loïc YSEBAERT, Prof.
role: PRINCIPAL_INVESTIGATOR
References: