Cesson Sevigne

Researchers are evaluating the safety, tolerance, and effects of elritercept, alone and combined with the JAK inhibitor ruxolitinib, in adults with myelofibrosis (MF). This Phase 2 study aims to learn how elritercept impacts the signs and symptoms of MF, how the body processes the drug, and its effects on anemia and blood cell counts. Elritercept is an investigational protein designed to boost red blood cell and platelet production by blocking certain signals that suppress blood formation. Participants receive elritercept as a subcutaneous injection either alone or in combination with oral ruxolitinib tablets. The study includes different groups based on prior treatments: those previously treated with JAK inhibitors and those currently on ruxolitinib with insufficient disease control or side effects limiting dose. A specific group in Brazil includes participants with no prior JAK inhibitor treatment. The study monitors participants over about 8 years, including long-term extension periods. During the study, participants will be regularly assessed for side effects, blood cell levels, and overall health. Researchers will track adverse events and serious side effects from informed consent through 30 days after the last dose. Other evaluations include laboratory tests, symptom assessments, and pharmacokinetic analyses to understand how elritercept behaves in the body. Participants agree to follow all study procedures and return for follow-up visits throughout the study period.

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are studying Philadelphia-negative myeloproliferative neoplasms (MPN), which include Polycythemia Vera (PV), essential thrombocythemia (ET), and prefibrotic myelofibrosis (PreMF). These chronic blood cancers involve specific mutations like JAK2V617F and carry a high risk of blood clots that can cause serious health problems. Current treatments include low-dose aspirin to reduce arterial clots, but patients still face risks of thrombosis and bleeding. This trial explores whether direct oral anticoagulants (DOACs), such as Apixaban or Rivaroxaban, might better prevent these clotting events in patients with the JAK2V617F mutation. Participants will be randomly assigned to receive either a DOAC (Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once daily) or low-dose aspirin (100 mg once daily). The study focuses on high-risk MPN patients with JAK2V617F mutation and will compare the effectiveness and safety of DOACs versus aspirin for preventing blood clots. Treatment will continue with close monitoring throughout the study. During the study, researchers will track the time until any arterial or venous blood clots occur over a 24-month follow-up period. Participants will undergo regular assessments to monitor clotting events, bleeding risks, and overall health. The trial aims to gather detailed information on how well these treatments prevent thrombosis and their safety profiles, helping to guide future care for patients with these blood disorders.

Researchers are evaluating the effectiveness of a hypnotherapy method called E2R in managing chronic insomnia in primary care. Chronic insomnia is commonly treated with hypnotic drugs in France, though these have notable side effects. Cognitive-behavioral therapy is recommended as a first-line non-drug treatment but is not widely used due to limited availability and time demands. The study aims to compare E2R hypnotherapy to standard care without hypnosis in patients with chronic insomnia. Patients will be randomly assigned to one of two groups: the E2R hypnosis group or the standard care control group. Those in the hypnosis group will receive four 30-minute hypnotherapy sessions over six weeks with a hypnotherapist located within 30 minutes of their home. The control group will receive the usual care by their general practitioner, which may include psychotherapy or medication but will exclude hypnosis. Both groups will have follow-up visits at three and six months after randomization. During the study, patients will complete questionnaires such as the Insomnia Severity Index and Pittsburgh Sleep Quality Index. Researchers will track use of psychotropic medications, any non-drug therapies, practice of self-hypnosis, events affecting sleep, and any adverse neuropsychiatric events. The main outcome measured is the severity of insomnia at six months. Safety and treatment effects will be assessed through these follow-ups, with the total study duration being six months.

Researchers are evaluating the combination of luspatercept and erythropoiesis stimulating agent (ESA) in adults with lower-risk myelodysplastic syndromes (LR-MDS) without ring sideroblasts, who have either not responded to ESA treatment or are ineligible for ESA. This phase I/II trial aims to find the optimal dose of the combination and to determine if adding ESA to luspatercept is more effective than luspatercept alone in patients without disease progression. The study has two parts: Part A is a dose-finding phase where patients receive luspatercept injections under the skin every 3 weeks at one of three doses (0.8 mg/kg, 1.33 mg/kg, or 1.75 mg/kg) combined with weekly subcutaneous injections of epoietin alfa (Eprex) at doses of 30,000 or 60,000 units. Part B compares the benefits of this combination treatment against luspatercept alone to assess superiority and efficacy. Participants will be closely monitored for toxicities and treatment benefits at specific time points, including day 21 and week 25. Assessments include blood tests, safety evaluations, and response to treatment. The study also includes ongoing pregnancy testing and adherence to contraception guidelines for participants of childbearing potential. The overall goal is to evaluate dose safety, effectiveness, and patient outcomes during the treatment periods.