Barletta

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 conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are studying financial toxicity in patients undergoing radiotherapy for cancer in Italy. They use a validated questionnaire called PROFFIT, which measures financial burden and its possible causes in cancer patients receiving radiotherapy. The study aims to compare financial toxicity among different patient groups based on their cancer type, treatment, age, and sex. Participants complete the PROFFIT questionnaire at three times: before starting radiotherapy, at the end of radiotherapy treatment, and 1 to 2 months after treatment during the first follow-up visit. Along with financial toxicity, researchers also explore how changes in financial burden relate to quality of life, side effects, and overall survival using additional questionnaires such as the EORTC QLQ-C30 and PRO-CTCAE. During the study, patients provide information through questionnaires that assess financial distress and quality of life. These assessments occur at baseline, end of treatment, and follow-up up to 12 months. The main outcome measured is the financial toxicity score over this period. This observational study is conducted in multiple centers in Italy and monitors patients' experiences related to financial strain during and after radiotherapy.

Researchers are evaluating the safety and effectiveness of a combination therapy of tucatinib, trastuzumab, and capecitabine in women with HER2-positive metastatic breast cancer. This study focuses on patients who have progressed after at least two prior anti-HER2 treatments and aims to observe how this treatment performs in a real-world clinical setting following approved indications and dosing guidelines. Tucatinib is an oral, highly selective HER2 tyrosine kinase inhibitor that has received regulatory approval based on previous trials demonstrating improved progression-free and overall survival in this patient population, including those with brain metastases. Patients will receive tucatinib in combination with trastuzumab and capecitabine according to their treating clinician's usual practice without additional treatment procedures imposed by the study. The study is observational and non-interventional, enrolling about 300 women who meet the treatment criteria. Data collection includes baseline characteristics, safety monitoring, and performance status evaluations during the period of tucatinib-based treatment. The study continues with a follow-up period lasting 18 months after treatment ends to monitor responses, survival, and any subsequent therapies. During participation, patients will undergo assessments including symptomatic response and best response evaluations by their clinicians following local practice. Safety and treatment effectiveness will be monitored throughout treatment and during the extended follow-up. Radiological and clinical data will be collected, and prior or subsequent treatments will be recorded to help understand the real-world impact of this therapy. The total observation time spans the treatment duration plus 18 months of follow-up to ensure comprehensive safety and efficacy evaluation.

Researchers are evaluating the impact of a healthy lifestyle-based Survivorship Care Plan (LS-SCP) on the quality of life in long-term lymphoma survivors who have been in remission for at least 3 years and up to 10 years. This prospective, randomized, open-label, multicenter study includes adults aged 18 to 50 who were treated for classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL), or Primary mediastinal large B-cell lymphoma (PMBCL). The study aims to assess how lifestyle changes influence the quality of life in these survivors. Participants are divided into two groups: the experimental group receives the LS-SCP intervention, which includes a Survivorship Care Plan, nutritional guidance, and physical activity, all followed for 6 months. Compliance in this group is monitored through bi-monthly automatic calls. The control group receives usual follow-up care without any specific lifestyle intervention. Both groups complete validated questionnaires and clinical assessments at the start, and then at 6 and 12 months after randomization. During the study, participants complete several quality of life and health-related questionnaires and undergo clinical evaluations at baseline, 6 months, and 12 months. The study measures global quality of life over a period of up to 30 months. Researchers track adherence to the intervention through regular calls in the experimental group and monitor all participants for safety and health outcomes through follow-up visits and questionnaires.

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.

Researchers are investigating treatments for patients with relapsed or refractory Hodgkin's lymphoma who are candidates for autologous stem-cell transplantation (ASCT). The study includes a phase I portion to determine the maximum tolerated dose (MTD) of atezolizumab when combined with the BEGEV chemotherapy regimen, followed by a phase IIb randomized controlled trial comparing BEGEV alone versus BEGEV combined with atezolizumab. The goal is to assess safety, response rates, and the potential benefits of adding atezolizumab to the standard treatment. In phase I, 6 to 18 patients receive atezolizumab plus BEGEV every three weeks for four cycles. Those without significant toxicity or disease progression after two cycles undergo stem cell mobilization with additional cycles of A-BEGEV plus granulocyte colony-stimulating factor, followed by high-dose therapy and ASCT. Patients who achieve complete response after ASCT receive consolidation therapy with atezolizumab every four weeks for six doses, with possible adjuvant radiotherapy if not previously treated. In phase IIb, 122 patients are randomized into two arms: one receiving BEGEV followed by ASCT, and the other receiving atezolizumab plus BEGEV followed by ASCT and consolidation with atezolizumab. Participants will be closely monitored throughout induction, consolidation, and follow-up phases, including assessment of adverse events, disease status, survival, and long-term toxicities. Follow-up lasts for 18 months after the last patient's treatment, with evaluations every six months to better understand long-term outcomes and patient prognosis. This comprehensive approach aims to clarify the safety and efficacy of combining atezolizumab with BEGEV chemotherapy in this patient population.

Researchers are investigating the relationship between vitamin D levels and head and neck cancer outcomes and treatment side effects. This observational study focuses on patients with histologically confirmed head and neck squamous cell carcinoma, particularly those with non-metastatic locally advanced stages who are receiving radical or adjuvant radiotherapy. The study aims to understand how vitamin D levels vary over time and how these levels relate to therapy toxicity and disease prognosis. The study will follow a multicenter cohort of patients prospectively, collecting vitamin D measurements at various time points. There are no investigational treatments or interventions being administered as part of the study; instead, participants will be observed during their standard clinical care, including bilateral neck irradiation when applicable. Researchers will analyze vitamin D level changes and assess their impact on radiotherapy side effects and disease outcomes. Participants will be monitored according to routine clinical practice, with vitamin D levels measured and recorded over a 7-week period as a primary outcome. The study will evaluate correlations between vitamin D variations, treatment toxicity, and disease progression. Overall, the participation involves regular clinical visits and laboratory tests as part of their standard care, with data collection focused on vitamin D status and patient health outcomes.