Cesson Sevigne

Researchers are evaluating the safety and tolerability of an investigational drug called elritercept, both alone and in combination with the JAK inhibitor ruxolitinib, in adults with myelofibrosis MF. The study also aims to understand how elritercept affects the signs and symptoms of MF, how the body processes the drug, and its effects on anemia when used with or without ruxolitinib. This is a Phase 2 open-label study focusing on participants with anemia related to MF.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

Researchers are investigating the use of a hypnotherapy method called E2R to manage chronic insomnia in primary care settings. Chronic insomnia is commonly treated with hypnotic drugs in France despite their risks, while cognitive-behavioral therapy is recommended but not widely available. This study aims to compare the effectiveness of E2R hypnotherapy against standard care without hypnosis in patients with chronic insomnia. Participants will be randomly assigned to one of two groups. One group will receive standard care from their general practitioner, which may include medications or psychotherapy but excludes hypnosis. The other group will undergo four 30-minute hypnotherapy sessions using the E2R method over six weeks, with additional practice of self-hypnosis. Both groups will have follow-up visits at 3 and 6 months after starting the study. During the study, patients will complete questionnaires assessing insomnia severity and sleep quality, record their use of psychotropic medications, and note any events affecting sleep. The research team will also monitor for neuropsychiatric side effects. These assessments occur at baseline, 3 months, and 6 months, with the main outcome measured by the Insomnia Severity Index at 6 months. Participation will last at least 6 months from enrollment.

Researchers are studying the combination of luspatercept and erythropoiesis stimulating agents ESA in adults with low-risk myelodysplastic syndromes LR-MDS without ring sideroblasts who have not responded to or cannot use ESA treatments. This trial aims to find the best dose of luspatercept combined with ESA and then compare the combinations effectiveness to luspatercept alone in patients whose disease has not progressed. The study has two parts Part A focuses on finding the optimal dose of luspatercept plus ESA by testing various dosing levels. Part B compares the combination treatment of luspatercept and ESA to luspatercept alone. Luspatercept is given by subcutaneous injection every three weeks, with doses adjusted in Part A. ESA epoetin alfa is also given as a weekly subcutaneous injection at doses determined in Part A. Participants will receive treatment according to their assigned group and be monitored regularly for side effects and treatment response. Researchers will evaluate toxicity early in treatment and measure benefits at 25 weeks. Additional outcomes include response rate at 3 months, response duration up to 24 months, and overall survival up to 30 months. The study includes informed consent, regular visits, laboratory tests, and safety assessments over the course of participation.