跳至主要内容
临床试验/NCT04985214
NCT04985214招募中不适用

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

University Hospital, Toulouse14 个研究点 分布在 1 个国家目标入组 464 人开始时间: 2020年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
464
试验地点
14
主要终点
Quality of life measurement

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Quality of life measurement

时间窗: 5 years

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

次要结局

  • Evaluation of patients factors(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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