Rimini

This research investigates adult patients with a subtype of B-cell Acute Lymphoblastic Leukemia (B-ALL) known as "triple negative" or Ph-/-/-, which lacks the most common gene rearrangements seen in adult B-ALL. The study aims to better understand this group, which represents about 61% of adult B-ALL cases and is associated with poor prognosis and limited targeted therapies. A key focus is on the role of the CRLF2 gene, often altered in this leukemia subtype, to identify patient clusters and potential biomarkers for new treatments. The study is non-interventional and translational, involving analysis of patient samples collected during routine clinical care without influencing treatment decisions. Biological samples, including peripheral blood, bone marrow, and saliva, will be examined using conventional methods and advanced techniques such as next-generation sequencing, flow cytometry, gene expression profiling, and copy number alteration analysis. These analyses will help characterize the disease and assess diagnostic tools like a cytofluorimetric assay to detect triple negative subgroups rapidly and economically. Participants will be followed for 36 months during which clinical data will be collected and stored in a dedicated database. The study evaluates biological markers associated with the leukemia subtype and monitors patient status through standard clinical assessments. This approach aims to improve understanding of triple negative adult B-ALL and support the development of new diagnostic and therapeutic strategies.

Researchers are creating a national registry in Italy for multiple myeloma, a type of blood cancer that makes up about 1.3% of all tumor diagnoses in men and 1.2% in women. This registry aims to track current clinical practices and describe how patients with multiple myeloma are diagnosed and treated across various hematology centers in Italy. The study also includes a patient-powered registry to encourage patient involvement and better understand treatment patterns and outcomes. The study is observational, meaning it will not involve any experimental treatments but will collect data on routine care and outcomes for patients diagnosed with active or symptomatic multiple myeloma since January 1, 2019. Both physicians and patients will contribute information to the registry, which will help monitor standard care practices nationwide. Participants will be followed to measure important outcomes such as overall survival and the time until the next treatment over a three-year period. The registry will collect data to analyze treatment approaches, patient characteristics, and survival, helping to identify changes and differences in care across Italy. Patients aged 18 years and older who can provide informed consent are eligible to participate, and there are no exclusion criteria.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

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 an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplantation. The study focuses on comparing the effects and safety of linvoseltamab against the standard treatment in this group of patients. This is a Phase 3 randomized, open-label study involving transplant-ineligible multiple myeloma patients. Participants will receive either linvoseltamab according to the study protocol or a combination of daratumumab, lenalidomide, and dexamethasone as the standard treatment. The trial includes an induction phase with daratumumab, lenalidomide, and dexamethasone followed by treatment with linvoseltamab or continuation of the standard therapy. All drugs are administered as directed by the study protocol. During the study, participants will be closely monitored for disease response and safety over a period of up to 11 years. Researchers will measure outcomes such as minimal residual disease status, progression-free survival based on specific criteria, and treatment response assessed by blinded independent review. Safety and long-term effects will also be evaluated throughout the study duration.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating treatments for patients with generalized Mantle Cell Lymphoma in this Phase 3 trial. The study aims to identify one of three treatment approaches as a future standard by comparing failure-free survival, which measures the time from treatment start until stable disease, disease progression, or death. Secondary goals include assessing overall survival, progression-free survival, response rates, safety, and tolerability of the treatments, as well as exploring factors like minimal residual disease and stem cell mobilization. Participants receive one of three treatment plans: the control arm with alternating R-CHOP and R-DHAP chemotherapy followed by autologous stem cell transplantation (ASCT); an experimental arm adding ibrutinib during induction and maintenance with ASCT; or an experimental arm with ibrutinib during induction and maintenance without ASCT. Chemotherapy includes drugs such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, Ara-C, and cisplatin. Ibrutinib is given in certain induction cycles and as daily maintenance for two years. ASCT conditioning uses specific chemotherapy regimens or total body irradiation depending on the site. During the study, participants undergo regular assessments including imaging, laboratory tests, and evaluations of response and side effects. Researchers monitor failure-free survival up to 10 years, along with secondary outcomes like overall survival, progression-free survival, and safety events. Follow-up includes measuring molecular remission, relapse timing, and quality of life. The total duration includes treatment, maintenance, and long-term observation, with safety and efficacy carefully tracked throughout.

The "Parco del Mare" pilot study investigates how moderate-intensity exercise performed in a natural green-blue space affects health outcomes like quality of life and physical performance in healthy adults. The study aims to provide evidence supporting the benefits of supervised physical activity in outdoor natural environments for public health promotion. Participants will be divided into two groups: an experimental group taking part in supervised exercise sessions twice a week for six months, and a control group receiving no intervention. Each exercise session consists of a warm-up lasting about 15 minutes, main exercises for about 30 minutes, and ending with 15 minutes of stretching and relaxation. Participants will be assessed at the beginning and after six months using validated tests and questionnaires to measure health parameters and quality of life. The primary outcome is the 12-Item Short Form Survey (SF-12) tracked through study completion, approximately one year. The study will monitor physical performance, anthropometric, and physiological measures to evaluate the program's feasibility and effectiveness.

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.