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

Last updated: September 18, 2023
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Treatment

Questionnaire

Clinical Study ID

NCT04985214
RC31/19/0465
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 464
Treatment Group(s): 1
Primary Treatment: Questionnaire
Phase:
Study Start date:
May 14, 2020
Estimated Completion Date:
January 01, 2025

Study Description

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

Connect with a study center

  • CH de Bayonne

    Bayonne, 64100
    France

    Active - Recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CHU de Grenoble

    Grenoble, 38043
    France

    Active - Recruiting

  • CH Versailles

    Le Chesnay, 78157
    France

    Active - Recruiting

  • CH Le Mans

    Le Mans, 72000
    France

    Active - Recruiting

  • CHU de Limoges

    Limoges, 87042
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69373
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU de Nîmes

    Nîmes, 30029
    France

    Active - Recruiting

  • CH de Perpignan

    Perpignan, 66000
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Loïc YSEBAERT

    Toulouse 9, 31059
    France

    Active - Recruiting

  • CHU de Tours

    Tours, 37044
    France

    Active - Recruiting

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