Pescara

Researchers are evaluating a chemo-free combination of rituximab and golcadomide (CC-99282) as a front-line treatment for older, frail patients newly diagnosed with diffuse large B-cell non-Hodgkin lymphoma (DLBCL). This phase II, multicenter study focuses on patients aged 80 or older who are considered frail based on a simplified geriatric assessment (sGA) and are not eligible for standard anthracycline-based chemotherapy. The study aims to assess the effectiveness of this treatment approach in this vulnerable population. Participants will receive an induction phase of up to six 28-day cycles consisting of golcadomide, rituximab, and dexamethasone only during the first cycle. Response to treatment will be evaluated after four and six cycles to identify patients who are responding. Those achieving at least a partial response will continue as planned, while non-responders will stop protocol treatment and switch to alternative regimens. After induction, involved site radiotherapy is permitted for PET-positive disease. Patients with at least partial response at the end of induction may then enter a consolidation phase with up to six additional 28-day cycles of golcadomide. Interim response checks during consolidation will identify disease progression, leading to treatment discontinuation if needed. Throughout the study, participants will undergo assessments including PET/CT or CT scans to evaluate disease and sarcopenia at baseline and end of treatment. Quality of life will be measured at study entry, during treatment, and follow-up. Follow-up visits will occur every three months for the first year and every six months in the second year, with a total follow-up duration of 24 months. Progression-free survival at 24 months is the primary outcome. Patients with disease progression will be considered treatment failures and followed for survival until study completion.

Researchers are conducting an international multicenter retrospective observational study to better understand the progression and clinical outcomes in patients with Essential Thrombocythemia (ET) who have the JAK2V617F mutation and later develop Polycythemia Vera (PV). The study follows updated 2022 diagnostic criteria for these myeloid blood disorders and includes two parts: a nested case-control study and a comparative retrospective cohort study. In the first part, patients who progressed from ET to PV by the end of 2020 are matched 1:1 with ET patients who have the same mutation but did not progress, based on year and age at ET diagnosis and disease duration. The second part compares patients with newly diagnosed PV who never had ET, matched similarly by year and age at diagnosis and disease duration, ensuring at least 5 years of follow-up for these patients. Participants' medical records will be reviewed retrospectively to compare clinical features and outcomes up to their baseline dates. The study aims to clarify phenotypic changes and clinical results in these patient groups. No interventions are administered, and the study focuses on analyzing existing data to assess progression and outcomes in these blood conditions.

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease (CAD). This prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.

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 treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating rapcabtagene autoleucel, a biological treatment given as a single infusion after lymphodepletion, in adults with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN). This Phase 2, open-label study aims to assess both the effectiveness and safety of this therapy in patients who have not responded well to at least two previous treatments. Participants must meet specific criteria including positive autoantibody tests and active disease symptoms measured by the SLEDAI-2K score. Participants will receive one infusion of rapcabtagene autoleucel following preparatory lymphodepletion therapy. The study does not mention comparator groups, focusing on monitoring responses to this single treatment. Treatment effects will be evaluated at 24 and 52 weeks after infusion to understand how well the therapy works over time. Throughout the study, participants will be closely monitored with various assessments to evaluate disease activity, safety, and response to treatment. Researchers will use laboratory tests, including autoantibody levels, and clinical evaluations to track changes in disease status. Safety monitoring will continue during the study period to identify any adverse effects. The total participation duration covers at least 52 weeks to capture both short-term and longer-term outcomes of the therapy.

Researchers are evaluating the effectiveness, safety, and patient-reported outcomes of standard treatments for people with relapsed or refractory multiple myeloma in real-world clinical settings. This study follows participants over 24 months to observe how current standard care works for those who have previously received treatment for this condition. The research includes participants who meet specific diagnostic criteria and have measurable disease based on recognized myeloma guidelines. The study does not involve any experimental treatment; instead, it observes patients receiving standard care as decided by their doctors. Participants include those who have undergone multiple prior therapies, including specific drug classes and targeted treatments, depending on the study period. The study covers different periods with slightly varied eligibility and treatment histories, including a group starting talquetamab treatment for relapsed or refractory multiple myeloma. Participants will be monitored for up to 52 months to evaluate their response to treatment, including overall response rates. Researchers will collect data on their health status, treatment history, and patient-reported outcomes. Safety and effectiveness will be assessed based on clinical evaluations and disease progression as determined by their healthcare providers throughout the study period.

Researchers are studying how vedolizumab, a medicine given just under the skin, is processed by children and teenagers with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). This study focuses on participants who have already responded to initial intravenous vedolizumab treatment. It aims to evaluate the medicine's behavior in the body, safety, and immune response in young patients aged 2 to 17 years. Participants will first receive three doses of vedolizumab through intravenous infusion at Day 1, Week 2, and Week 6, with dosing based on their weight. Those who respond clinically by Week 14 will then receive subcutaneous vedolizumab injections for 20 weeks, either every 2 weeks or every 4 weeks depending on weight. After completing treatment at Week 34, some participants may continue treatment in an extension study, while others will have follow-up safety visits 18 weeks after their last dose. Throughout the study, participants will visit the clinic multiple times for assessments including blood tests to measure vedolizumab levels, safety checks, and monitoring of disease activity. Researchers will observe the steady-state blood concentrations of vedolizumab at Week 34 to understand how the drug remains in the body over time. Safety and immune reactions will also be closely monitored during and after treatment to ensure participant well-being.

Researchers are evaluating the combination of Elranatamab, Daratumumab, and Lenalidomide compared to Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in people with newly diagnosed multiple myeloma who are not eligible for transplant. Elranatamab is a bispecific antibody that targets T-cells and multiple myeloma cells to trigger targeted immune cell killing. The study has two parts: Part 1 focuses on safety, tolerability, and optimal dosing of Elranatamab combinations, while Part 2 compares clinical benefits including minimal residual disease negative complete response rates and progression-free survival between the two treatment regimens. In Part 1, participants receive Elranatamab combined with Daratumumab and Lenalidomide or with Lenalidomide alone to determine safe dose levels. This phase includes non-randomized and randomized cohorts. In Part 2, participants are randomly assigned to receive either the combination of Elranatamab, Daratumumab, and Lenalidomide or the combination of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone. Treatment schedules and doses are managed according to study protocols to evaluate efficacy and safety. Participants undergo regular assessments including monitoring for dose-limiting toxicities in Part 1 from the first dose through 28 days, and in Part 2, evaluation of progression-free survival up to 97 months and minimal residual disease negative complete response at 12 months after randomization. Safety and tolerability are closely monitored throughout the study, with ongoing follow-up to assess treatment effects and outcomes over time.