Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia (THEMIS)

Toulouse University Hospital

Status: Enrolling

Conditions: Chronic Lymphoid Leukemia

Treatments: Other: Ambulatory medical assistance

Study type: Interventional

Funder types: Other

Identifiers

NCT05350826

RC31/21/0340

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 2 patient groups

Ambulatory medical assistance

Experimental group

Description:

Patient benefiting from the ambulatory medical assistance nurse program in addition to conventional care for patients chronic lymphoid leukemia under targeted therapy

Treatment:

Other: Ambulatory medical assistance

Conventional care

No Intervention group

Description:

Patient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy