Informations générales (source: ClinicalTrials.gov)

NCT05350826 En recrutement IDF
Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study (THEMIS)
Interventional
  • Leucémies
  • Leucémie lymphoïde
  • Leucémie chronique lymphocytaire à cellules B
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.
 Voir le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL NOVO GONZALEZ En recrutement IDF 04/07/2024 11:05:06  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 En recrutement Contact (sur clinicalTrials)
Centre Léon Bérard - Lyon - France Anne-Sophie MICHALLET, MD En recrutement Contact (sur clinicalTrials)
CH Bretagne Atlantique Vannes - Vannes - France Mélanie MERCIER, MD En recrutement Contact (sur clinicalTrials)
CH du Mans - Le Mans - France Kamel LARIBI, MD En recrutement Contact (sur clinicalTrials)
CH Sud Réunion - Saint Pierre - ILE DE LA Reunion - France Hugo LEGENDRE, MD En recrutement Contact (sur clinicalTrials)
CHRU de Nancy - Nancy - France Pierre FEUGIER, PhD En recrutement Contact (sur clinicalTrials)
CHRU Dijon - Dijon - France Cédric ROSSI, MD En recrutement Contact (sur clinicalTrials)
CHU d'Angers - Angers - France Aline CLAVERT, MD En recrutement Contact (sur clinicalTrials)
CHU DE BREST Hôpital A.Morvan - Brest - France Hussam SAAD, MD En recrutement Contact (sur clinicalTrials)
CHU de Reims- Hôpital R.Debré - Reims - France Anne QUINQUENEL, MD En recrutement Contact (sur clinicalTrials)
CHU de RENNES - Rennes - France Sophie DE GUIBERT, MD En recrutement Contact (sur clinicalTrials)
Hôpital Bretonneau - Tours - France Caroline DARTIGEAS, MD En recrutement Contact (sur clinicalTrials)
Hôpital Emile MULLER - Mulhouse - France Bernard DRENOU, MD En recrutement Contact (sur clinicalTrials)
Hôpital Estaing - Clermont-Ferrand - France Romain GUIZEZ, PhD En recrutement Contact (sur clinicalTrials)
Hôpital Saint-Louis - 75008 - Paris - France Catherine THIEBLEMONT, MD En recrutement Contact (sur clinicalTrials)
Institut de Cancérologie du Gard - Nîmes - France Eric JOURDAN, MD En recrutement 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



- Patient who has already benefited from ambulatory medical assistance nurse program
with a previous treatment

- Pregnant women

- Patients under judicial protection