Viagrande

Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies MAB in patients with B-cell Non-Hodgkin Lymphoma NHL treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating a treatment approach for patients with metastatic pulmonary large-cell neuroendocrine carcinoma LCNEC who have not received prior therapy. This prospective multicenter phase II study aims to assess the combination of durvalumab with carboplatin and etoposide chemotherapy as a first-line treatment in this population. Participants will receive an induction phase of intravenous durvalumab 1500 mg on day 1, carboplatin AUC 5 on day 1, and etoposide 100 mgsqm on days 1-3 every three weeks for up to 4 cycles or until disease progression, unacceptable side effects, or other stopping reasons. Following this, patients enter a maintenance phase receiving durvalumab 1500 mg intravenously every 4 weeks for up to 24 additional courses, totaling 28 courses or 2 years of treatment, whichever comes first. Throughout the study, participants will undergo regular clinical assessments to monitor treatment effects, side effects, and disease status. Researchers will measure treatment efficacy using established criteria over one year. Safety and tolerability will also be closely tracked. The total duration of participant involvement may last up to 2 years or until disease progression or intolerable toxicity occurs.