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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).
Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral therapy | Patients included in the PK-E3i clinical study or patients with hemopathies starting treatment with oral therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Questionnaire on the quality of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of patients factors | Collect of clinical and socio-professional characteristics of the patient | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib…)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loïc YSEBAERT, Prof. | Contact | 0531156351 | 33 | ysebaert.loic@iuct-oncopole.fr |
| Fabien DESPAS, MD | Contact | fabien.despas@univ-tlse3.fr |
| Name | Affiliation | Role |
|---|---|---|
| Loïc YSEBAERT, Prof. | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de Bayonne | Recruiting | Bayonne | 64100 | France |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
|
| CHU de Grenoble | Recruiting | Grenoble | 38043 | France |
|
| CH Versailles | Recruiting | Le Chesnay | 78157 | France |
|
| CH Le Mans | Recruiting | Le Mans | 72000 | France |
|
| CHU de Limoges | Recruiting | Limoges | 87042 | France |
|
| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
|
| Institut Paoli Calmettes | Recruiting | Marseille | 13273 | France |
|
| CHU de Montpellier | Recruiting | Montpellier | 34295 | France |
|
| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
|
| CH de Perpignan | Recruiting | Perpignan | 66000 | France |
|
| Hospices Civils de Lyon | Recruiting | Pierre-Bénite | 69495 | France |
|
| Loïc YSEBAERT | Recruiting | Toulouse | 31059 | France |
|
| CHU de Tours | Recruiting | Tours | 37044 | France |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |