Clinical trial NCT05350826: Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia
Official title: Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Lymphoid Leukemia
Keywords: Targeted therapy
Ambulatory medical assistance
Chronic lymphoid leukemia
Real-world costs
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: This research is a prospective randomized multicenter comparative study in 2 parallel groups (1: 1) : patients benefiting from the ambulatory medical assistance nurse program in addition to conventional care versus patients benefiting from conventional care. For each patient, data will be collected during 2 years.

Eligibility criteria: 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

Exclusion Criteria:

* Patient who has already benefited from ambulatory medical assistance nurse program with a previous treatment
* Pregnant women
* Patients under judicial protection

Primary outcomes:
measure: Ambulatory medical assistance efficiency
timeFrame: 1 year
Secondary outcomes:
measure: Survival of patients
timeFrame: 1 and 2 years after initiation of targeted therapy
measure: Quality of life of patients
timeFrame: at inclusion, 1 and 2 years after initiation of targeted therapy
measure: Cost-effectiveness analysis
timeFrame: at 1 and 2 years
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: CH Sud Réunion
state: ILE DE LA Reunion
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHU DE BREST Hôpital A.Morvan
city: Clermont-Ferrand
country: France
facility: Hôpital Estaing
city: Dijon
country: France
facility: CHRU Dijon
city: Le Mans
country: France
facility: CH du Mans
city: Lyon
country: France
facility: Centre Hospitalier Lyon sud
city: Lyon
country: France
facility: Centre Léon Bérard
city: Mulhouse
country: France
facility: Hôpital Emile MULLER
city: Nancy
country: France
facility: CHRU de Nancy
city: Nîmes
country: France
facility: Institut de Cancérologie du Gard
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Reims
country: France
facility: CHU de Reims- Hôpital R.Debré
city: Rennes
country: France
facility: CHU de RENNES
city: Tours
country: France
facility: Hôpital Bretonneau
city: Vannes
country: France
facility: CH Bretagne Atlantique Vannes
Study officials:
affiliation: University Hospital, Toulouse
name: Loïc YSEBAERT, MD, PhD
role: STUDY_DIRECTOR
References: