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Chronic Lymphoid LeukemiaTHEMISNCT05350826

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

A study testing Ambulatory medical assistance in people with Chronic Lymphoid Leukemia, run by University Hospital, Toulouse at 16 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphoid Leukemia
What is being tested?
Ambulatory medical assistance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
16 sitesFrance
Study dates
13 Apr 2023to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

16 sites in 1 country.

Loïc YSEBAERT, MD, PhD contact

0531156351 ext. 33

ysebaert.loic@iuct-oncopole.fr

Sandra DE BARROS contact

0561145982 ext. 33

debarros.s@chu-toulouse.fr

16 sites in 1 country

France16 sites, 16 recruiting

  • CHU d'Angers

    Angers

    Aline CLAVERT, MD

    Recruiting

  • CHU DE BREST Hôpital A.Morvan

    Brest

    Hussam SAAD, MD

    Recruiting

  • Hôpital Estaing

    Clermont-Ferrand

    Romain GUIZEZ, PhD

    Recruiting

  • CHRU Dijon

    Dijon

    Cédric ROSSI, MD

    Recruiting

  • CH du Mans

    Le Mans

    Kamel LARIBI, MD

    Recruiting

  • Centre Hospitalier Lyon sud

    Lyon

    Emmanuelle FERRANT, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Anne-Sophie MICHALLET, MD

    Recruiting

  • Hôpital Emile MULLER

    Mulhouse

    Bernard DRENOU, MD

    Recruiting

  • CHRU de Nancy

    Nancy

    Pierre FEUGIER, PhD

    Recruiting

  • Institut de Cancérologie du Gard

    Nîmes

    Eric JOURDAN, MD

    Recruiting

  • Hôpital Saint-Louis

    Paris, 75008

    Catherine THIEBLEMONT, MD

    Recruiting

  • CHU de Reims- Hôpital R.Debré

    Reims

    Anne QUINQUENEL, MD

    Recruiting

  • CHU de RENNES

    Rennes

    Sophie DE GUIBERT, MD

    Recruiting

  • CH Sud Réunion

    Saint-Pierre, ILE de LA Reunion

    Hugo LEGENDRE, MD

    Recruiting

  • Hôpital Bretonneau

    Tours

    Caroline DARTIGEAS, MD

    Recruiting

  • CH Bretagne Atlantique Vannes

    Vannes

    Mélanie MERCIER, MD

    Recruiting

Other trials in France

About this study

Official title: Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study

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.

Read the 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.

Being tested
Ambulatory medical assistance
Keywords
Targeted therapy, Ambulatory medical assistance, Chronic lymphoid leukemia, Real-world costs
Medical subject headings
Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05350826
Study groupRoleWhat they receive
Ambulatory medical assistanceExperimentalPatient benefiting from the ambulatory medical assistance nurse program in addition to conventional care for patients chronic lymphoid leukemia under targeted therapy
Receives: Other: Ambulatory medical assistance
Conventional careNo interventionPatient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ambulatory medical assistance efficiency

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

    Measured: 1 year

Secondary outcomes (3)

  1. Survival of patients

    Compare the survival of patients with or without ambulatory medical assistance at 1 and 2 years

    Measured: 1 and 2 years after initiation of targeted therapy

  2. Quality of life of patients

    Compare the quality of life of patients with or without ambulatory medical assistance with European Organisation for Research and Treatment of Cancer C30 scores

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

  3. Cost-effectiveness analysis

    Perform a cost-effectiveness analysis at 1 and 2 years comparing costs and survival from a community perspective

    Measured: at 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start13 Apr 2023
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05350826
Sponsor's protocol ID
RC31/21/0340
Acronym
THEMIS
Status last verified
Sep 2023
First submitted
7 Apr 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ambulatory medical assistance in people with Chronic Lymphoid Leukemia, run by University Hospital, Toulouse at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Loïc YSEBAERT, MD, PhD (0531156351 ext. 33, ysebaert.loic@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulatory medical assistance efficiency (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05350826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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