Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy
EVEREST
1 other identifier
observational
464
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2020
CompletedFirst Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 21, 2023
September 1, 2023
4.6 years
July 26, 2021
September 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
5 years
Secondary Outcomes (1)
Evaluation of patients factors
5 years
Study Arms (1)
Oral therapy
Patients included in the PK-E3i clinical study or patients with hemopathies starting treatment with oral therapy.
Interventions
Eligibility Criteria
Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib…)
You may qualify if:
- 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
You may not qualify if:
- Pregnant women
- Persons under legal protection of adults
- Patients under judicial protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
CH de Bayonne
Bayonne, 64100, France
CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
CHU de Grenoble
Grenoble, 38043, France
CH Versailles
Le Chesnay, 78157, France
CH Le Mans
Le Mans, 72000, France
CHU de Limoges
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13273, France
CHU de Montpellier
Montpellier, 34295, France
CHU de Nîmes
Nîmes, 30029, France
CH de Perpignan
Perpignan, 66000, France
Hospices Civils de Lyon
Pierre-Bénite, 69495, France
Loïc YSEBAERT
Toulouse, 31059, France
CHU de Tours
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loïc YSEBAERT, Prof.
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 2, 2021
Study Start
May 14, 2020
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share