Rionero In Vulture

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 whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. This Phase 3 study compares zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The goal is to see if the new combination improves progression-free survival. Participants receive treatments through intravenous infusions of study drugs including zilovertamab vedotin, rituximab or its biosimilar, cyclophosphamide, doxorubicin, and vincristine, along with oral prednisone or prednisolone as per approved guidelines. Some may receive rescue medication such as granulocyte colony-stimulating factor (G-CSF) if needed. The study is open-label and conducted across multiple centers. During the study, participants are closely monitored for how long they live without their disease worsening, with follow-up up to approximately 50 months. Assessments include imaging scans like PET to evaluate disease status, heart function tests, and regular evaluations of overall health and side effects. Safety is monitored throughout, and researchers measure progression-free survival as the primary outcome to determine the effectiveness of the treatments.

Researchers are collecting epidemiological data on adults newly diagnosed with myelodysplastic syndrome (MDS) to better understand the disease. The study aims to develop a network of Italian regional registries that use a unified electronic case report form to store patient data. This network will allow for the aggregation and analysis of anonymous data from different regions and enable combining this information with other international registries. There are no specific treatments or interventions in this study as it focuses on data collection and registry development. The main goal is to gather consistent and comprehensive epidemiological data through regional registries across Italy. Participants will have their diagnosis and related information recorded in the registry. Researchers will monitor outcomes over six years, including the incidence and prevalence of MDS, overall response rates, survival rates, progression-free survival, and progression to acute myeloid leukemia (AML). The study involves long-term follow-up to track these outcomes and improve understanding of MDS epidemiology.

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with lutetium (177Lu) vipivotide tetraxetan. This study is a long-term, prospective, multicenter, observational research project designed to describe routine clinical use of this treatment in real-world settings. The focus is on understanding patient experiences and outcomes outside of clinical trials. The study observes patients receiving lutetium (177Lu) vipivotide tetraxetan as prescribed by their doctor, without any experimental interventions introduced by the study itself. The observation period starts from the beginning of treatment and continues for up to 18 months after treatment ends. No additional procedures or changes to treatment are made by the study team. Participants will be monitored through regular clinical assessments to track their progression-free survival, which measures how long patients remain free from disease worsening after treatment. The study collects primary data during this observation to provide insight into the real-world effectiveness and safety of lutetium (177Lu) vipivotide tetraxetan for men with mCRPC. Overall, involvement in this study lasts up to 18 months post-treatment.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.

Researchers are conducting an open-label, multicenter, randomized phase III trial to compare two treatment approaches in elderly patients aged 65 and older with Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular grade IIIb lymphoma. The study evaluates the addition of vitamin D supplementation to a standard prephase treatment with oral prednisone, followed by six cycles of immunochemotherapy with either R-CHOP or R-miniCHOP. The study aims to explore the effects of vitamin D supplementation during immunochemotherapy in this patient population, with a focus on progression-free survival over 54 months. Participants are randomly assigned in a 1 to 1 ratio to either the standard arm (Arm A) or the experimental arm (Arm B). Both arms receive a prephase of oral prednisone for 7 days followed by six 21-day cycles of immunochemotherapy with R-CHOP or R-miniCHOP. Patients in Arm B also receive vitamin D3 (cholecalciferol) supplementation starting with a loading dose based on baseline vitamin D levels, followed by weekly maintenance doses throughout immunochemotherapy and the option to continue monthly supplementation for up to two years. Adjustments to vincristine dosing during prephase and immunochemotherapy are allowed based on clinical judgement. Throughout the study, participants undergo baseline assessments and regular monitoring including vitamin D levels, treatment toxicity, and response evaluations. Patients experiencing treatment-related delays longer than four weeks discontinue study treatment but continue survival follow-up. The primary outcome measure is progression-free survival assessed at the end of treatment and up to 54 months. The study also includes safety monitoring and long-term follow-up to assess sustained outcomes and adverse events.

Oligometastatic breast cancer occurs when breast cancer has spread to only a few other parts of the body. Patients with this limited spread may live longer than those with more widespread disease. Researchers are exploring whether adding local treatments like stereotactic body radiotherapy (SBRT), which delivers high doses of radiation in a few sessions without surgery, can improve disease control and survival compared to standard whole-body treatments such as chemotherapy or hormonal therapy. This study is a multicenter retrospective analysis aimed at better understanding the benefits of SBRT in this patient group. The study focuses on patients who have received SBRT to extracranial sites of oligometastatic breast cancer, with treatments delivering a minimum dose of 50 Gy EQD2 in up to 12 sessions. As a retrospective database study, it collects data from multiple institutions on patients treated with SBRT following the Oligocare definition. The study reviews treatment details and outcomes from patients aged 18 years and older with confirmed breast cancer and limited metastatic spread. Participants will have their medical records reviewed to assess progression-free survival, which is the primary outcome measure tracked from January 2010 to December 2023. Researchers will analyze disease control and survival outcomes following SBRT treatment. Since this is a retrospective study, there is no direct patient involvement, but the study relies on comprehensive data collection and evaluation from existing patient records across multiple centers.