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Clinical Trials/NCT04985214
NCT04985214
Recruiting
N/A

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

University Hospital, Toulouse14 sites in 1 country464 target enrollmentMay 14, 2020
ConditionsQuality of Life

Overview

Phase
N/A
Intervention
Not specified
Conditions
Quality of Life
Sponsor
University Hospital, Toulouse
Enrollment
464
Locations
14
Primary Endpoint
Quality of life measurement
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2020
End Date
January 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Quality of life measurement

Time Frame: 5 years

Evaluation of the quality of life score, throught the quality of life scale (higher score associated with poor quality of life)

Secondary Outcomes

  • Evaluation of patients factors(5 years)

Study Sites (14)

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