Chronic Lymphoid Leukemia Clinical Trial
— THEMISOfficial 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.
| Status | Recruiting |
| Enrollment | 450 |
| Est. completion date | July 1, 2025 |
| Est. primary completion date | July 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU d'Angers | Angers | |
| France | CHU DE BREST Hôpital A.Morvan | Brest | |
| France | Hôpital Estaing | Clermont-Ferrand | |
| France | CHRU Dijon | Dijon | |
| France | CH du Mans | Le Mans | |
| France | Centre Hospitalier Lyon sud | Lyon | |
| France | Centre Léon Bérard | Lyon | |
| France | Hôpital Emile MULLER | Mulhouse | |
| France | CHRU de Nancy | Nancy | |
| France | Institut de Cancérologie du Gard | Nîmes | |
| France | Hôpital Saint-Louis | Paris | |
| France | CHU de Reims- Hôpital R.Debré | Reims | |
| France | CHU de RENNES | Rennes | |
| France | CH Sud Réunion | Saint Pierre | ILE DE LA Reunion |
| France | Hôpital Bretonneau | Tours | |
| France | CH Bretagne Atlantique Vannes | Vannes |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Toulouse |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Survival of patients | Compare the survival of patients with or without ambulatory medical assistance at 1 and 2 years | 1 and 2 years after initiation of targeted therapy | |
| Secondary | 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 | at inclusion, 1 and 2 years after initiation of targeted therapy | |
| Secondary | Cost-effectiveness analysis | Perform a cost-effectiveness analysis at 1 and 2 years comparing costs and survival from a community perspective | at 1 and 2 years |
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