Informations générales (source: ClinicalTrials.gov)
Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study (THEMIS)
Interventional
N/A
University Hospital, Toulouse (Voir sur ClinicalTrials)
avril 2023
juillet 2025
29 juin 2024
The emergence of targeted therapy (ibrutinib, venetoclax, acalabrutinib) has
revolutionized the management practices of chronic lymphoid leukemia due to their
effectiveness. However, targeted therapy induces a significant additional cost compared
to treatment with immunochemotherapy and their use can be problematic due to the frequent
occurrence of side effects, which can be serious. In order to improve the current
management of patients treated with targeted therapy, the aim of this study is to
evaluate the ambulatory medical assistance nurse program. Ambulatory medical assistance
is based on regular telephone calls to patient's homes by a specialist nurse and consists
of the monitoring, detection and early management of possible adverse effects of targeted
therapy, in link with the hematologist. The main objective of this clinical research is
to determine efficiency of the ambulatory medical assistance nurse program.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | GONZALEZ | 14/02/2025 09:03:21 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Lyon sud - Lyon - France | Emmanuelle FERRANT, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Anne-Sophie MICHALLET, MD | Contact (sur clinicalTrials) | |||
| CH Bretagne Atlantique Vannes - Vannes - France | Mélanie MERCIER, MD | Contact (sur clinicalTrials) | |||
| CH du Mans - Le Mans - France | Kamel LARIBI, MD | Contact (sur clinicalTrials) | |||
| CH Sud Réunion - Saint Pierre - ILE DE LA Reunion - France | Hugo LEGENDRE, MD | Contact (sur clinicalTrials) | |||
| CHRU de Nancy - Nancy - France | Pierre FEUGIER, PhD | Contact (sur clinicalTrials) | |||
| CHRU Dijon - Dijon - France | Cédric ROSSI, MD | Contact (sur clinicalTrials) | |||
| CHU d'Angers - Angers - France | Aline CLAVERT, MD | Contact (sur clinicalTrials) | |||
| CHU DE BREST Hôpital A.Morvan - Brest - France | Hussam SAAD, MD | Contact (sur clinicalTrials) | |||
| CHU de Reims- Hôpital R.Debré - Reims - France | Anne QUINQUENEL, MD | Contact (sur clinicalTrials) | |||
| CHU de RENNES - Rennes - France | Sophie DE GUIBERT, MD | Contact (sur clinicalTrials) | |||
| Hôpital Bretonneau - Tours - France | Caroline DARTIGEAS, MD | Contact (sur clinicalTrials) | |||
| Hôpital Emile MULLER - Mulhouse - France | Bernard DRENOU, MD | Contact (sur clinicalTrials) | |||
| Hôpital Estaing - Clermont-Ferrand - France | Romain GUIZEZ, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis - 75008 - Paris - France | Catherine THIEBLEMONT, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie du Gard - Nîmes - France | Eric JOURDAN, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Men and women over the age of 18
- Patients with chronic lymphoid leukemia and starting treatment with targeted
therapy: ibrutinib, venetoclax or acalabrutinib, alone or in combination with
obinutuzumab or rituximab in 1L or R/R according to the indications of the Marketing
Authorization.
- Be able to understand the objective and the constraints related to the research
- Patient having signed the consent form
- Patient with Social Security affiliation or equivalent
- Person able to speak on the phone
- Men and women over the age of 18
- Patients with chronic lymphoid leukemia and starting treatment with targeted
therapy: ibrutinib, venetoclax or acalabrutinib, alone or in combination with
obinutuzumab or rituximab in 1L or R/R according to the indications of the Marketing
Authorization.
- Be able to understand the objective and the constraints related to the research
- Patient having signed the consent form
- Patient with Social Security affiliation or equivalent
- Person able to speak on the phone
- Patient who has already benefited from ambulatory medical assistance nurse program
with a previous treatment
- Pregnant women
- Patients under judicial protection