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

NCT ID: NCT05350826

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-13

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lymphoid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ambulatory medical assistance

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

Group Type EXPERIMENTAL

Ambulatory medical assistance

Intervention Type OTHER

Ambulatory medical assistance is a patient-empowerment program and consists to programmed phone calls (bi-monthly for the first 6 months then monthly for the following 6 months) delivered by an oncology nurse, in link with the hematologist.

Conventional care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ambulatory medical assistance

Ambulatory medical assistance is a patient-empowerment program and consists to programmed phone calls (bi-monthly for the first 6 months then monthly for the following 6 months) delivered by an oncology nurse, in link with the hematologist.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Loïc YSEBAERT, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Toulouse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CH Sud Réunion

Saint-Pierre, ILE de LA Reunion, France

Site Status RECRUITING

CHU d'Angers

Angers, , France

Site Status RECRUITING

CHU DE BREST Hôpital A.Morvan

Brest, , France

Site Status RECRUITING

Hôpital Estaing

Clermont-Ferrand, , France

Site Status RECRUITING

CHRU Dijon

Dijon, , France

Site Status RECRUITING

CH du Mans

Le Mans, , France

Site Status RECRUITING

Centre Hospitalier Lyon sud

Lyon, , France

Site Status RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Hôpital Emile MULLER

Mulhouse, , France

Site Status RECRUITING

CHRU de Nancy

Nancy, , France

Site Status RECRUITING

Institut de Cancérologie du Gard

Nîmes, , France

Site Status RECRUITING

Hôpital Saint-Louis

Paris, , France

Site Status RECRUITING

CHU de Reims- Hôpital R.Debré

Reims, , France

Site Status RECRUITING

CHU de RENNES

Rennes, , France

Site Status RECRUITING

Hôpital Bretonneau

Tours, , France

Site Status RECRUITING

CH Bretagne Atlantique Vannes

Vannes, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Loïc YSEBAERT, MD, PhD

Role: CONTACT

0531156351 ext. 33

Sandra DE BARROS

Role: CONTACT

0561145982 ext. 33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hugo LEGENDRE, MD

Role: primary

Aline CLAVERT, MD

Role: primary

Hussam SAAD, MD

Role: primary

Romain GUIZEZ, PhD

Role: primary

Cédric ROSSI, MD

Role: primary

Kamel LARIBI, MD

Role: primary

Emmanuelle FERRANT, MD

Role: primary

Anne-Sophie MICHALLET, MD

Role: primary

Bernard DRENOU, MD

Role: primary

Pierre FEUGIER, PhD

Role: primary

Eric JOURDAN, MD

Role: primary

Catherine THIEBLEMONT, MD

Role: primary

Anne QUINQUENEL, MD

Role: primary

Sophie DE GUIBERT, MD

Role: primary

Caroline DARTIGEAS, MD

Role: primary

Mélanie MERCIER, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC31/21/0340

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.