NCT05350826

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

April 7, 2022

Last Update Submit

September 18, 2023

Conditions

Chronic Lymphoid Leukemia

Keywords

Targeted therapyAmbulatory medical assistanceChronic lymphoid leukemiaReal-world costs

Outcome Measures

Primary Outcomes (1)

  • Ambulatory medical assistance efficiency

    To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L

    1 year

Secondary Outcomes (3)

  • Survival of patients

    1 and 2 years after initiation of targeted therapy

  • Quality of life of patients

    at inclusion, 1 and 2 years after initiation of targeted therapy

  • Cost-effectiveness analysis

    at 1 and 2 years

Study Arms (2)

Ambulatory medical assistance

EXPERIMENTAL

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

Other: Ambulatory medical assistance

Conventional care

NO INTERVENTION

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

Interventions

Ambulatory medical assistanceOTHER

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.

Ambulatory medical assistance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

CH Sud Réunion

Saint-Pierre, ILE de LA Reunion, France

RECRUITING

CHU d'Angers

Angers, France

RECRUITING

CHU DE BREST Hôpital A.Morvan

Brest, France

RECRUITING

Hôpital Estaing

Clermont-Ferrand, France

RECRUITING

CHRU Dijon

Dijon, France

RECRUITING

CH du Mans

Le Mans, France

RECRUITING

Centre Hospitalier Lyon sud

Lyon, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hôpital Emile MULLER

Mulhouse, France

RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

Institut de Cancérologie du Gard

Nîmes, France

RECRUITING

Hôpital Saint-Louis

Paris, 75008, France

RECRUITING

CHU de Reims- Hôpital R.Debré

Reims, France

RECRUITING

CHU de RENNES

Rennes, France

RECRUITING

Hôpital Bretonneau

Tours, France

RECRUITING

CH Bretagne Atlantique Vannes

Vannes, France

RECRUITING

MeSH Terms

Conditions

Leukemia, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Loïc YSEBAERT, MD, PhD

    University Hospital, Toulouse

    STUDY DIRECTOR

Central Study Contacts

Loïc YSEBAERT, MD, PhD

CONTACT

0531156351ysebaert.loic@iuct-oncopole.fr

Sandra DE BARROS

CONTACT

0561145982debarros.s@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 28, 2022

Study Start

April 13, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(16)