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

Last updated: September 18, 2023
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic

Treatment

Ambulatory medical assistance

Clinical Study ID

NCT05350826
RC31/21/0340
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orrituximab 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

Exclusion Criteria:

  • Patient who has already benefited from ambulatory medical assistance nurse programwith a previous treatment
  • Pregnant women
  • Patients under judicial protection

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: Ambulatory medical assistance
Phase:
Study Start date:
April 13, 2023
Estimated Completion Date:
July 01, 2025

Study 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.

Connect with a study center

  • CH Sud Réunion

    Saint Pierre, ILE DE LA Reunion
    France

    Active - Recruiting

  • CHU d'Angers

    Angers,
    France

    Active - Recruiting

  • CHU DE BREST Hôpital A.Morvan

    Brest,
    France

    Active - Recruiting

  • Hôpital Estaing

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CHRU Dijon

    Dijon,
    France

    Active - Recruiting

  • CH du Mans

    Le Mans,
    France

    Active - Recruiting

  • Centre Hospitalier Lyon sud

    Lyon,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Hôpital Emile MULLER

    Mulhouse,
    France

    Active - Recruiting

  • CHRU de Nancy

    Nancy,
    France

    Active - Recruiting

  • Institut de Cancérologie du Gard

    Nîmes,
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris, 75008
    France

    Active - Recruiting

  • CHU de Reims- Hôpital R.Debré

    Reims,
    France

    Active - Recruiting

  • CHU de RENNES

    Rennes,
    France

    Active - Recruiting

  • Hôpital Bretonneau

    Tours,
    France

    Active - Recruiting

  • CH Bretagne Atlantique Vannes

    Vannes,
    France

    Active - Recruiting

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