Ascoli Piceno

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. This Phase 3 study aims to assess the safety, tolerability, and effectiveness of odronextamab alone and compared to the current standard treatments, including rituximab combined with different types of chemotherapy. The study also examines side effects, drug levels in the blood, antibody responses against odronextamab, and the impact on quality of life and daily activities. The study consists of two parts: Part 1 is non-randomized and focuses on the safety and tolerability of odronextamab given alone. Part 2 is randomized and controlled, comparing odronextamab to rituximab combined with chemotherapy regimens such as CHOP, CVP, or Bendamustine-containing therapies. All treatments are administered according to the study protocol. Participants receive these treatments to evaluate how well odronextamab works versus standard care. Participants will undergo various assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor bone marrow and liver function, and evaluations of side effects up to two years. Researchers will track dose-limiting toxicities within 35 days and assess complete response rates over 30 months. Safety and side effects will be monitored continuously, and quality of life will also be evaluated. The total length of participation depends on treatment and follow-up schedules defined in the protocol.

Researchers are evaluating the impact of a mobile health (m-health) solution on improving the self-management skills of adults with Type 2 Diabetes Mellitus (T2DM) living in the Marche region of Italy. This randomized clinical trial compares the personalized m-health solution, integrated with patients' Electronic Patient Records (EPR), to usual care. The main goal is to assess changes in glycated haemoglobin (HbA1c) levels from the start of the intervention through 18 months, along with other health-related factors like medication adherence, lifestyle habits, self-efficacy, and quality of life. Participants in the treated group will receive training and personalized setup of the m-health solution, which includes mobile applications for tracking health data, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers at Diabetes Centres (CADs) will monitor patient data via a dedicated EPR interface and maintain communication as needed. The intervention begins at the CADs and continues at participants' homes, with follow-up evaluations at 6, 12, and 18 months. Throughout the study, participants will complete self-administered questionnaires and clinical assessments during routine physician visits. Data will be collected from the m-health solution, clinical evaluations, and focus groups to evaluate usability, patient experience, and cost-effectiveness. Importantly, no extra visits or laboratory tests beyond usual care are required. The total observation period spans 18 months from baseline to final follow-up.

Researchers are comparing the effects of a new low glucose peritoneal dialysis solution called XyloCore to traditional glucose-based solutions in patients with End-Stage Renal Disease (ESRD) who are undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD). This Phase 3, randomized, controlled, open-label, multicenter study aims to assess the efficacy and safety of XyloCore over a 6-month period while maintaining blinded evaluation of key outcomes. Participants will be randomly assigned to receive either the investigational XyloCore solution—available in Low, Medium, or High Strength formulations based on glucose concentration—or to continue their standard glucose-based peritoneal dialysis treatments such as Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova, or Equibalance. All patients will continue using Extraneal (7.5% Icodextrin) for their long-dwell nocturnal exchange. The number and osmotic strength of daily short dwell exchanges can be adjusted by investigators as needed, with the goal of achieving a weekly total Kt/V urea clearance above 1.7. During the study, participants will be monitored for dialysis effectiveness, mainly by measuring total weekly Kt/V urea at 24 weeks. Clinical status will be regularly assessed, including evaluation of safety and tolerability. Randomization is stratified to balance patients with diabetes and those treated with only one daily exchange. The study's open-label design includes blinded assessment of primary endpoints to reduce bias, and treatment adjustments will be tailored to each patient's clinical situation throughout the trial.

Researchers are conducting an open-label, randomized, multicenter phase III study to evaluate the feasibility of allogeneic stem cell transplantation (HSCT) in patients with higher-risk myelodysplastic syndromes (HR-MDS). The study compares two approaches: hypomethylating therapy (HMT) followed by HSCT versus HSCT upfront in patients with less than 10% bone marrow blasts, and conventional chemotherapy (CHT) versus HMT followed by HSCT in patients with more than 10% bone marrow blasts. This non-inferiority trial aims to assess which treatment strategy is more feasible based on the proportion of patients who successfully receive HSCT over four years. Participants receive treatments based on their bone marrow blast counts. Those with under 10% blasts receive azacitidine, administered as 75 mg/m2 subcutaneously daily for 7 days every 28 days, followed by HSCT or HSCT upfront. Patients with more than 10% blasts are treated with standard chemotherapy consisting of two cycles of intravenous induction and consolidation therapy using cytarabine and daunorubicin before HSCT. The study compares these treatment regimens to determine the best sequence for transplantation. During the study, participants are closely monitored for treatment feasibility, including assessments of successful HSCT receipt. Researchers evaluate outcomes over a four-year period, focusing on the proportion of patients completing the transplantation process. Patients must meet specific health criteria and provide informed consent. Safety and treatment adherence are observed throughout the trial, ensuring comprehensive data on the transplantation strategies in HR-MDS patients aged 18 to 70 years.

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 investigating the best treatment approach for patients with acute coronary syndrome (ACS) who have intermediate narrowing (40-70% diameter stenosis) in coronary arteries not responsible for the current heart event. The study compares strategies based on optical coherence tomography (OCT), a detailed imaging method identifying vulnerable plaques, against physiology-based methods like fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), and resting full-cycle ratio (RFR) that measure blood flow to guide treatment. This trial involves about 1420 ACS patients from around 40 sites worldwide and aims to clarify which method better guides intervention in these intermediate lesions. Participants are randomly assigned to one of two groups: the OCT-guided group or the physiology-guided group. In the OCT group, lesions showing specific vulnerability signs on imaging, such as thin fibrous caps and macrophage clusters, or very small minimum lumen areas, will receive treatment using a drug-eluting stent (DES). In the physiology group, treatment with DES occurs if flow measurements (iFR, RFR, or FFR) indicate significant blockage. If these criteria are not met, intervention may be deferred. Both groups use advanced devices for imaging and flow measurement to guide decisions. During the study, participants will be closely monitored for cardiac events such as cardiac death or spontaneous heart attacks related to the treated vessel over a period of 2 years, with follow-up extending to 5 years. Researchers will assess these outcomes to determine the effectiveness of each strategy. The study includes detailed imaging, physiological assessments, and clinical evaluations to track patient progress and safety throughout the trial.

Researchers are investigating the effectiveness and safety of mocravimod, a drug, as an additional and maintenance treatment for adults with acute myeloid leukemia (AML) who are undergoing allogeneic hematopoietic cell transplantation (HCT). This phase III, multi-center, randomized, double-blinded, placebo-controlled trial focuses on adult AML patients classified as high-risk or intermediate-risk, including those in their first or second remission. The study excludes patients with acute promyelocytic leukemia. Participants will receive mocravimod or a placebo alongside their transplantation procedure. The treatment is given as an adjunctive therapy during the transplantation process and continued as maintenance afterward. All participants will undergo planned allogeneic HCT from fully matched related or unrelated donors, or haploidentical donors using peripheral blood stem cell grafts. Conditioning regimens and GvHD prophylaxis based on tacrolimus (TAC) will be used as per protocol. Throughout the study, participants will be monitored for relapse-free survival over 12 months. Researchers will evaluate treatment safety and efficacy, with assessments including performance status and organ function. The total study duration includes transplantation, treatment, and follow-up periods to ensure comprehensive evaluation of mocravimod's role in this patient population.

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 evaluating treatments for frail patients newly diagnosed with multiple myeloma. This multicenter, open-label phase II study compares two treatment combinations: daratumumab with teclistamab and daratumumab with talquetamab. The main goal is to measure progression free survival at 18 months in these two groups. The study involves four phases: an initial treatment phase where patients receive a fixed duration of either teclistamab plus daratumumab or talquetamab plus daratumumab; a treatment-free interval (TFI); a re-treatment phase for patients whose disease progresses, continuing their assigned combination; and a post-treatment follow-up phase. All drugs are given as subcutaneous injections and treatment continues until disease progression or intolerable side effects. Participants will undergo regular assessments including monitoring of disease status according to IMWG criteria. Researchers will track progression free survival over 18 months to evaluate effectiveness. Safety and tolerability will also be monitored throughout the study. The total participation time includes initial treatment, possible re-treatment, and follow-up after treatment ends.

This research aims to collect and analyze data on patients diagnosed with plasmablastic lymphoma (PBL), a rare type of lymphoma. It is an international, multicenter, observational, and retrospective study that focuses on understanding the clinical and pathological characteristics, treatment approaches, outcomes, and prognostic factors including clinical features, biomarkers, and radio-metabolic data in PBL patients. The study also involves a centralized pathological review to assess the accuracy of diagnoses and to recommend an immunohistochemical diagnostic panel for PBL. The study gathers information from real-life cases of PBL diagnosed between January 1, 2000, and December 31, 2022. It does not involve new treatments but collects existing clinical and pathological data from multiple centers worldwide. Exploratory analyses will be conducted to further characterize PBL, enhancing understanding of this lymphoma subtype. Participants will have their medical records and histopathological samples reviewed. Researchers will evaluate diagnosis accuracy, staging, management, treatment outcomes, and prognostic factors. The primary measure is overall survival over 36 months. Only patients with confirmed PBL diagnosis and complete records will be included. The study aims to improve knowledge about PBL through detailed data collection and analysis without direct intervention or treatment changes.