Viagrande

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include 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 incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating a treatment combination for patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC) who have not received prior therapy. This phase II, prospective multicenter study aims to assess the effectiveness of carboplatin, etoposide, and durvalumab as a first-line treatment for this aggressive lung cancer. The study focuses on patients with advanced disease stages who need new treatment options. Participants receive intravenous carboplatin (dose based on AUC 5 on day 1), etoposide (100 mg/sqm on days 1 to 3), and durvalumab (1500 mg on day 1) every three weeks for up to four cycles during the induction phase. After this, those without disease progression may continue durvalumab maintenance therapy every four weeks for up to 24 additional courses or two years, whichever comes first. Treatment may stop earlier due to disease progression, side effects, or patient choice. Throughout the study, patients undergo regular monitoring, including tumor assessments to measure response according to RECIST criteria. Researchers track blood counts, liver and kidney function, coagulation, and any side effects. The primary outcome is the treatment's efficacy over one year. The study ensures patient safety with ongoing evaluations and follows participants for up to two years or until disease progression or unacceptable toxicity occurs.