Rimini

This research aims to investigate adult patients with triple negative B-cell Acute Lymphoblastic Leukemia B-ALL who do not have the most common genetic rearrangements linked to the disease. These patients often have a poor prognosis and lack targeted therapies. The study focuses on understanding the molecular characteristics of this subgroup, especially regarding CRLF2 gene alterations, which are important in both adult and pediatric cases and may influence treatment outcomes. The study is non-interventional and observational, meaning treatment decisions are made by doctors as usual and are not influenced by participation. Patients diagnosed with primary or secondary B-ALL will be enrolled and their blood, bone marrow, and saliva samples collected for detailed biological analysis using various laboratory techniques, including gene sequencing and flow cytometry. Both prospective and retrospective patient groups will be studied over a planned period of 36 months. Participants will provide biological samples and clinical data, which will be recorded in a dedicated database. Researchers will evaluate molecular markers to identify patient subgroups, assess potential biomarkers, and correlate findings with survival outcomes. The study aims to develop a rapid and cost-effective method for identifying these leukemia subtypes, with ongoing monitoring and data collection continuing throughout the three-year study duration.

This observational study aims to create a national registry in Italy for multiple myeloma to monitor routine clinical practice and describe the standard care used for diagnosis and treatment. Multiple myeloma accounts for a small percentage of tumor diagnoses in Italy, with incidence rates of 9.5 per 100,000 males and 8.1 per 100,000 females. The registry will help analyze current treatment patterns and patient demographics to address future changes in care. The study involves a non-interventional, multicenter registry collecting both retrospective and prospective data from patients diagnosed with multiple myeloma since January 1, 2019. Data will be gathered using an electronic platform, and patients will be enrolled consecutively during their regular appointments after providing informed consent. Patients participating in other studies can also be included, with baseline and survival data collected for those in interventional trials. Participants will have hospital visits every six months, where clinical data and patient-reported outcomes will be recorded. Researchers will assess overall survival and time to next treatment over three years, along with patient-reported outcomes and costs incurred by patients. The study provides long-term monitoring without altering patients usual care, and participation duration may vary depending on individual follow-up.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are studying adult patients with generalized myasthenia gravis gMG who are positive for acetylcholine receptor AChR antibodies. The study aims to gather real-world evidence from Italian clinical practice on how efgartigimod alfa affects clinical outcomes and patient-reported experiences in those treated for gMG. This observational study will follow patients over a total duration of up to 23 months. The study involves collecting primary data at a baseline visit and follow-up visits at 6 and 12 months after baseline. Researchers will also gather secondary data from medical charts covering the 12 months before baseline, including details on MG-related therapies, exacerbations, hospitalizations, and the patients medical history. The treatment with efgartigimod alfa is decided independently by the treating physician as part of routine care, not influenced by study participation. Participants will be monitored through clinical assessments and questionnaires measuring changes in MG-Activities of Daily Living MG-ADL scores and the percentage achieving minimal symptom expression MSE up to 12 months. Additional measures include quality of life, fatigue, anxiety and depression, sleep quality, and caregiver burden scores tracked over the same period. The study collects comprehensive data to understand disease experience and treatment impact, with safety and outcomes evaluated throughout the 23-month period.

Researchers are studying an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. The study aims to compare the effects and safety of linvoseltamab combined with standard treatment against the standard treatment alone. This is a Phase 3 randomized, open-label trial sponsored by the European Myeloma Network B.V. Participants will receive either the combination of daratumumab, lenalidomide, dexamethasone, and linvoseltamab or continued treatment with daratumumab, lenalidomide, and dexamethasone alone. Treatments will be given according to the study protocol, and participants will be randomly assigned to one of these two groups. The study will continue for up to 11 years to assess long-term effects. During the study, participants will undergo various assessments including measurements of minimal residual disease MRD, progression-free survival, overall survival, and response rates. Quality of life will also be evaluated using standardized questionnaires. Safety will be closely monitored by tracking adverse events and laboratory tests. Participants will be followed up for up to 11 years, with regular visits to assess disease status and treatment impact.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

This research aims to evaluate the effects of a moderate-intensity exercise program performed in a green-blue space in Italy on the well-being of healthy adults. The study focuses on improvements in health, quality of life, physical performance, body measurements, and physiological parameters, providing important evidence for public health initiatives. Participants will be divided into two groups an experimental group that takes part in supervised outdoor exercise sessions twice a week for six months, and a control group that does not receive any exercise intervention but maintains usual daily activities. Each exercise session lasts one hour and includes warm-up, main exercises, and stretching and relaxation, all guided by trained professionals. Throughout the study, participants will be assessed with validated tests and questionnaires at the start and after six months to monitor changes in health parameters and quality of life. The main outcome measure is the 12-Item Short Form Survey SF-12 evaluated over about one year. The study also includes close monitoring of physical performance and other health indicators to understand the programs impact.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are conducting a phase III randomized clinical trial to study early stage Follicular Lymphoma, a type of lymphoma that has not been treated before. The trial compares the effects of local Radiotherapy alone versus Radiotherapy combined with the drug Obinutuzumab. The goal is to better understand how these treatments work for patients with early stage Follicular Lymphoma and to evaluate progression-free survival and other outcomes. Participants will be randomly assigned to one of two groups one group will receive involved-site Radiotherapy at a standard dose of 24Gy alone the other group will receive the same Radiotherapy followed by Obinutuzumab infusionsfour weekly doses plus four additional doses every three weeks, totaling eight doses. This open-label study is conducted across multiple centers. During the study, participants will be monitored for treatment response and side effects over a period of up to 45 months, including 9 months of treatment and 36 months of follow-up. Assessments include imaging scans, laboratory tests, and molecular analyses to evaluate response rates, disease progression, and molecular markers. Safety and adverse events will be tracked throughout, with long-term follow-up to understand treatment effects and disease status.