Frosinone

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 studying ischemic stroke cases in patients who are taking oral anticoagulants for atrial fibrillation or other heart rhythm problems that can cause clots. This study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate short- and long-term outcomes related to different secondary prevention strategies to prevent stroke recurrence. The study includes two parts: a retrospective phase (ASPERA-R) and a prospective phase (ASPERA-P), involving multiple centers worldwide. The University of L'Aquila coordinates data collection, analysis, and management. The retrospective part (ASPERA-R) will collect data for 5 years from the study start, with centers having 6 months to enter existing patient data. The prospective part (ASPERA-P) will enroll patients for 2 years after study approval, followed by 5 years of follow-up. Participants must have had an acute ischemic stroke while on oral anticoagulants, with confirmed imaging showing stroke lesions. The study will observe different secondary prevention treatments, including continuing the same anticoagulant or switching therapies, to compare outcomes. Participants undergo baseline assessments of demographics, clinical status, and brain imaging at the time of their stroke. Researchers will track new strokes or transient ischemic attacks at 90 days, 1 year, and 5 years after the initial stroke. They will also monitor safety events like bleeding complications and other major ischemic events such as heart attacks. Data collection includes ongoing clinical evaluations and imaging studies to identify factors linked with stroke recurrence and treatment safety.

Researchers are evaluating the addition of gemtuzumab ozogamicin to standard chemotherapy to reduce minimal residual disease (MRD) levels in adults aged 18 to 60 with favorable or intermediate-risk acute myeloid leukemia (AML) who have not been previously treated. This phase 3 study focuses on patients with de novo AML, excluding certain subtypes and mutations, to see if MRD-driven post-remission therapy, such as autologous or allogeneic stem cell transplant, improves anti-leukemic outcomes. Participants will receive induction and consolidation chemotherapy combining gemtuzumab ozogamicin with daunorubicin and cytarabine. The treatment aims to lower MRD before transplant and guide risk assignment for subsequent therapy intensity. The study is conducted at multiple centers and targets patients with specific AML risk profiles, excluding those with prior chemotherapy (except limited hydroxyurea use) or radiotherapy. During the study, patients will be closely monitored for MRD levels, along with assessments of organ function and overall health status. Primary outcomes include achieving MRD negativity within two months. Safety evaluations and follow-up will track treatment effects, adherence, and patient response. The study duration and detailed follow-up schedules are determined by the protocol to ensure comprehensive evaluation of treatment impact.

Researchers are evaluating outcomes and their predictors in various neurosurgical conditions using standardized measures agreed upon by multiple centers. The goal is to improve research quality, enable data comparison, and create a common language for routine clinical practice. This approach aims to influence therapeutic decisions and provide more precise guidance to patients undergoing neurosurgery by identifying clinical, cognitive, and psychological factors before and after surgery. The study collects pre- and postoperative clinical, cognitive, and psychological data from patients with a wide range of neurosurgical pathologies including tumors, vascular, traumatic, spinal, functional, peripheral nervous system, and malformative conditions. Data collection includes sociodemographic information, medical history, comorbidities, anesthesiological details, and complications. Enrollment occurs through Neurosurgery Departments, and follow-up timing varies by pathology. Artificial intelligence will be used to analyze associations between preoperative indicators and postoperative outcomes. Participants are followed for up to five years during which comprehensive data are collected. Assessments include clinical evaluations, cognitive and psychological testing, and monitoring of complications and comorbid conditions. The study aims to describe detailed pre- and postoperative status and to identify predictors of outcomes to aid clinical decision-making. Long-term data collection supports understanding of neurosurgical effectiveness and patient quality of life over time.

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.

This research focuses on rare cerebrovascular diseases (rCVDs) such as CADASIL, Fabry disease, COL4A1 syndrome, Sneddon syndrome, and Moyamoya arteriopathy. These rare conditions contribute to a portion of strokes that often remain undiagnosed due to challenges in recognition by clinicians. The study aims to better understand the clinical features and natural progression of these diseases and to improve diagnosis and care through a large Italian network, addressing the limited knowledge and geographical disparities in expertise across Italy. The study does not specify particular interventions but involves creating a clinical and research network to empower diagnostic pathways for rCVDs. This network will help gather detailed clinical and genetic data from patients diagnosed with these rare conditions, who have undergone at least one brain MRI study. The initiative seeks to enhance diagnostic accuracy, share knowledge, and support appropriate management including genetic counseling. Participants will be monitored for up to 12 months to describe their phenotypic characteristics and observe the natural history of their disease. Evaluations include clinical, genetic, and neuroradiological assessments based on existing diagnoses. The study supports improved patient management through better understanding of disease features and progression, aiming to fill gaps in diagnosis and care, especially for patients in Southern Italy.