Clinical trials

Chronic lymphocytic leukemia is a malignant blood disorder characterized by the proliferation of abnormal B lymphocytes in the blood, lymph nodes, and bone marrow. It generally occurs after age 70 and is the fourth most common blood cancer in France, following multiple myeloma, diffuse large B-cell lymphoma, and myelodysplastic syndromes. Treatments have advanced since 2015 with the introduction of immunotherapy and targeted therapies. The BCL2 inhibitor (venetoclax) is one of these innovative treatments. It is recommended as first-line therapy and for relapse in combination with anti-CD20 monoclonal antibodies and Bruton's tyrosine kinase inhibitors. Early studies showed that initial administration of venetoclax as monotherapy could lead to lysis syndrome as early as the first few days of treatment. This risk was correlated with the venetoclax dose and tumor burden. Prevention guidelines were subsequently proposed to guide management. This risk is therefore assessed before treatment begins (low, moderate, high), based on lymph node size and circulating lymphocyte count. For patients at moderate and high risk, a treatment strategy is recommended that includes hyperhydration and uric acid-lowering agents, which may require hospitalization in some cases. The introduction of combination therapies has improved the depth and duration of response (obinutuzumab + venetoclax and ibrutinib + venetoclax). Venetoclax is added after the initiation of partner agents (22 days after obinutuzumab and 3 cycles after ibrutinib). This initial phase of treatment may reduce the risk of hemolytic syndrome. We propose here to reassess the risk of hemolytic syndrome before starting venetoclax in order to simplify management.

Management of hemopathies has progressed with the arrival of new drugs such as CAR T-cells (Chimeric Antigen Receptor T-cells), immunotherapy and targeted therapies, while increasing emphasis is being placed on outpatient care. The emergence of oral therapies has simplified the treatment pathway, but they are not without their undesirable effects, which can sometimes lead to treatment suspension or even discontinuation. These undesirable effects may be related either to the haemopathy (pain, general signs, fatigue, malnutrition, infection, etc.), or to the toxicity of the treatments, or to co-morbidities. It is therefore essential to detect and manage these adverse effects in real time. In patients treated with oral therapy, poor compliance (\<80% of doses taken) can have a direct impact on progression-free survival and sometimes on overall survival (Dashputre et al, Williams et al). It is therefore imperative for patients to follow prescribed treatments correctly, and for doctors to check for the absence of side-effects that could adversely affect patient safety and quality of life. Monitoring of these side effects varies from one center to another: it can be "classic", with a call from the patient or GP in the event of an event; it can be telephone-based (AMA-type coordination nurse for Ambulatory Medical Assistance); and finally, it can be electronic via a remote monitoring application. Monitoring by electronic application has been evaluated in oncology, with a benefit on early detection of side effects or signs of disease progression The human resources and organization of hematology departments are highly heterogeneous, and few studies have been carried out for patients treated long-term (≥ 6 months) with oral therapy. For these patients, therapeutic compliance is one of the parameters to be assessed, in order to optimize dose-intensity and duration of response. We propose here to compare two types of follow-up for patients due to start oral therapy: standard follow-up and follow-up by electronic application (Cureety).