Evaluating a nurse program for patients with chronic lymphoid leukemia
Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study
NA · University Hospital, Toulouse · NCT05350826
This study is testing whether having a special nurse check in regularly by phone can help people with chronic lymphoid leukemia better manage side effects from their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Drugs / interventions | obinutuzumab, rituximab, ibrutinib, acalabrutinib |
| Locations | 16 sites (Saint Pierre, ILE DE LA Reunion and 15 other locations) |
| Trial ID | NCT05350826 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of an ambulatory medical assistance nurse program for patients with chronic lymphoid leukemia undergoing targeted therapy. The program involves regular telephone monitoring by a specialist nurse to detect and manage potential side effects associated with treatments like ibrutinib, venetoclax, and acalabrutinib. Patients will be randomly assigned to receive either the nurse program alongside standard care or standard care alone, with data collected over a two-year period to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with chronic lymphoid leukemia starting targeted therapy.
Not a fit: Patients who have previously participated in the ambulatory medical assistance nurse program or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance patient management and reduce complications from targeted therapies in chronic lymphoid leukemia.
How similar studies have performed: Other studies have shown promise in using nurse-led programs for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint Pierre, ILE DE LA Reunion and 15 other locations
- 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, 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)
Study contacts
- Study coordinator: Loïc YSEBAERT, MD, PhD
- Email: ysebaert.loic@iuct-oncopole.fr
- Phone: 0531156351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Lymphoid Leukemia, Targeted therapy, Ambulatory medical assistance, Chronic lymphoid leukemia, Real-world costs