Ascoli Piceno

Researchers are studying an investigational drug called linvoseltamab in adults who have a moderate risk of developing multiple myeloma. This group includes patients with precancerous conditions known as High-Risk Monoclonal Gammopathy of Undetermined Significance HR-MGUS and Non-High-Risk Smoldering Multiple Myeloma NHR-SMM. The main goal is to understand how well linvoseltamab can eliminate abnormal plasma cells and laboratory signs associated with these conditions. Participants will receive linvoseltamab following a step-up dosing regimen to assess safety and tolerability before moving to one of four full dosing regimens. The study is divided into a safety run-in phase and an expansion phase where participants are assigned to different dose groups without randomization. Linvoseltamab is given according to the study protocol, with dosing schedules designed to monitor effects and side effects. During the study, participants will be closely monitored through regular safety observations over 35 days and longer-term assessments up to 5.5 years. Researchers will track adverse events, treatment responses including complete response rates, laboratory results, and the presence of antibodies against the drug. Blood levels of linvoseltamab are measured up to 9 months. This comprehensive monitoring will help understand the drugs impact and safety over time.

Researchers are studying an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. The trial is a Phase 3, open-label, randomized study comparing odronextamab to rituximab combined with different chemotherapy regimens, which represent the current standard treatment. The study aims to evaluate the safety, tolerability, and how well odronextamab works compared to standard care, including side effects, drug levels in the blood, antibody development against the drug, and quality of life impacts. The study has two parts Part 1 is a non-randomized safety run-in where all participants receive odronextamab alone to assess safety and tolerability. In Part 2, participants are randomly assigned to one of two groups one receiving odronextamab followed by maintenance therapy with odronextamab, and the other receiving rituximab combined with chemotherapy followed by rituximab maintenance. Chemotherapy regimens include CHOP, CVP, or bendamustine, administered as per protocol. Participants will be monitored regularly for treatment side effects, drug concentrations, and immune responses for up to 5 years. Researchers will assess responses using imaging and other tests at multiple time points, including complete response at 30 months and progression-free survival up to 5 years. Quality of life and physical function will also be evaluated using standardized questionnaires. Safety and adverse events will be tracked for up to 2 years, ensuring comprehensive follow-up throughout the study duration.

Researchers are evaluating a mobile health m-health solution designed to support self-management skills in adults with Type 2 Diabetes Mellitus T2DM living in the Marche region of Italy. This randomized clinical trial compares the use of the personalized m-health tool integrated with the Electronic Patient Record EPR against usual diabetes care, focusing on changes in glycated hemoglobin HbA1c levels over an 18-month period. The study aims to enhance patients abilities to manage their condition through technology combined with healthcare collaboration. Participants are randomly assigned to one of two groups the treated group receives regular care plus access to the m-health solution, while the control group continues with standard care alone. The m-health solution includes mobile apps for tracking health data such as blood sugar, lifestyle habits, and diet, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers will monitor patient data through an integrated platform and communicate as needed. The intervention begins at diabetic centers and continues at participants homes. Participants will undergo evaluations at the start and at 6, 12, and 18 months, including clinical assessments, questionnaires, and data collected from the m-health solution. Researchers will assess changes in diabetes severity, medication adherence, lifestyle habits, self-efficacy, quality of life, and the usability and satisfaction with the m-health tool. There are no additional visits or lab tests beyond usual care. The study includes cost-effectiveness analysis and gathers participant feedback to understand their experience with the intervention.

This research aims to compare the effects of a new low glucose peritoneal dialysis solution called XyloCore against standard glucose-based solutions in patients with End-Stage Renal Disease ESRD who are undergoing Continuous Ambulatory Peritoneal Dialysis CAPD. The study is randomized, controlled, and open-label with blinded assessment of the main outcomes, conducted over a 6-month period. It includes patients already using common glucose peritoneal dialysis solutions and Extraneal for their long-dwell exchange. Participants will be randomly assigned to receive either the experimental XyloCore solution or continue with their current glucose peritoneal dialysis solutions. XyloCore is provided in low, medium, or high strengths matched to the glucose concentration of the patients prior prescription, while the control group maintains their usual glucose-based solutions. Both groups will continue using Extraneal for the nocturnal long-dwell exchange. Dialysis prescriptions may be adjusted by investigators to meet a target dialysis adequacy measure KtV > 1.7 per week. Throughout the study, participants will undergo regular assessments including measurement of dialysis adequacy total weekly KtVurea, blood tests such as HbA1c, cholesterol levels, hemoglobin, and insulin, as well as monitoring of kidney function, fluid removal, fatigue, and adverse events. The study includes follow-up visits for up to 6 months, with careful monitoring of safety and treatment effects. The trial is sponsored by Iperboreal Pharma Srl and uses centralized randomization with blinded evaluation of primary endpoints.

The trial investigates treatment options for adults aged 18 to 70 with newly diagnosed higher-risk myelodysplastic syndromes HR-MDS, focusing on the feasibility of allogeneic stem cell transplantation HSCT. It compares upfront HSCT with pre-treatment using azacitidine or conventional chemotherapy based on the patients bone marrow blast counts. This phase III, open-label, randomized multicenter study aims to determine whether pre-transplant treatments affect the ability to proceed with HSCT. Participants are assigned to groups depending on their bone marrow blast levels. Those with 10% or more blasts receive either conventional chemotherapy following a 37 protocol or azacitidine given subcutaneously at 75 mgm2 daily for 7 days every 28 days for at least 4 cycles before HSCT if a suitable donor is available. Patients with less than 10% blasts may receive upfront HSCT or azacitidine prior to HSCT under similar dosing schedules. The study evaluates these different sequences of therapy to assess HSCT feasibility. During the study, participants undergo regular assessments over four years to monitor whether they proceed to HSCT. Researchers track treatment outcomes, safety, and overall feasibility by measuring the proportion of randomized patients who receive the transplantation. The trial includes follow-up for at least four years to collect data on these outcomes and ensure participant safety and treatment adherence throughout the process.

Researchers are evaluating the effect of adding gemtuzumab ozogamicin to standard chemotherapy for adults aged 18 to 60 with newly diagnosed favorable or intermediate-risk acute myeloid leukemia AML. This phase 3 study aims to reduce minimal residual disease MRD levels before transplantation and assess whether MRD-driven post-remission therapy can improve anti-leukemic outcomes. The study excludes patients with certain genetic markers or prior treatments to focus on a specific AML subgroup. Participants receive induction treatment with gemtuzumab, daunorubicin, and cytosine arabinoside, followed by consolidation therapy with adjusted doses of these drugs. After consolidation, patients undergo either autologous or allogeneic stem cell transplantation based on their MRD level. This MRD-guided approach helps tailor the intensity of post-remission therapy. Throughout the study, participants undergo MRD assessments to measure treatment activity, with the primary outcome being MRD negativity two months after starting therapy. Researchers also monitor kidney and liver function, heart health, and overall compliance with study procedures. The study involves regular clinical observations and assessments to evaluate the effectiveness of the combined treatment and its impact on MRD levels over time.

Researchers are evaluating the efficacy and safety of mocravimod as an additional and maintenance treatment in adults with acute myeloid leukemia AML undergoing allogeneic hematopoietic cell transplantation HCT. This phase III, multicenter, randomized, double-blinded, placebo-controlled trial focuses on AML patients receiving stem cell transplants to assess relapse-free survival and overall survival outcomes. Participants will be assigned to one of three groups receiving either 3 mg or 1 mg of mocravimod orally once daily for 12 months, or a matching placebo orally once daily for the same duration. The study drugs are taken continuously over the one-year treatment period following transplantation, with the goal to evaluate mocravimod as a supportive therapy alongside standard care. During the study, participants will be monitored with regular clinical assessments, including evaluation of relapse-free survival at 12 months and overall survival at 24 months. Safety and efficacy will be closely observed through follow-up visits. The total participation duration spans at least one year of treatment plus extended survival monitoring, ensuring comprehensive data collection on the impact of mocravimod in this patient population.

This research aims to evaluate the effects of adding Vitamin D supplementation to standard immunochemotherapy in elderly patients diagnosed with Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma. This open-label, randomized phase III trial compares two treatment approaches to understand whether Vitamin D affects outcomes in patients aged 65 and older undergoing immunochemotherapy. Participants are randomly assigned to one of two groups. Both groups receive a prephase of oral prednisone followed by six cycles of immunochemotherapy with R-CHOP or R-miniCHOP every 21 days. The experimental group also receives Vitamin D supplementation starting before treatment and continuing through immunochemotherapy according to a set schedule, including loading doses based on baseline Vitamin D levels and weekly maintenance. Patients may continue Vitamin D supplementation after treatment for up to two years. During the study, participants undergo baseline assessments and are monitored regularly through the treatment cycles. Researchers track progression-free survival over 54 months as the primary outcome, along with overall survival, response rates, Vitamin D levels, physical functioning, and fatigue. Safety and treatment adherence are also monitored, with follow-up visits extending up to several years to evaluate long-term outcomes.

Researchers are studying ziftomenib, an investigational drug targeting the menin pathway, in patients with acute myeloid leukemia AML who have specific genetic mutations NPM1-m or KMT2A-r and have not yet received treatment. The study includes two separate phase 3, randomized, double-blind, placebo-controlled trials assessing ziftomenib combined with standard therapies. The goal is to evaluate the benefits and risks of adding ziftomenib to current standard treatments for AML. One study, called the Nonintensive Therapy Study, enrolls older patients or those with serious medical conditions to receive venetoclax and azacitidine standard care plus either ziftomenib or placebo. The second study, the Intensive Therapy Study, involves medically fit patients treated with cytarabine and daunorubicin known as 73 plus ziftomenib or placebo during induction, followed by cytarabine plus ziftomenib or placebo in consolidation, and a maintenance phase where patients receive ziftomenib or placebo alone. Patients are randomly assigned to these groups without knowing which treatment they receive. Participants will undergo regular assessments to monitor overall survival, event-free survival, remission rates, and measurable residual disease in bone marrow up to 36 months after enrollment. Safety is evaluated through adverse event reporting and drug concentration measurements. Patient-reported outcomes related to health are also collected. The study involves oral and intravenous drug administration with visits scheduled according to treatment phases. Participation lasts up to 36 months, including treatment and follow-up periods.

Researchers are evaluating treatments for frail patients newly diagnosed with multiple myeloma. This open-label phase II study has two groups one receiving teclistamab with daratumumab, and the other receiving talquetamab with daratumumab. The main goal is to measure how long patients live without disease progression over 18 months. The study includes four phases an initial treatment phase with fixed durations of teclistamab-daratumumab or talquetamab-daratumumab a treatment-free interval a re-treatment phase if the disease progresses and a post-treatment follow-up period. All drugs are given by subcutaneous injection and continued until disease progression or intolerable side effects. Participants will have regular assessments including disease progression checks using established criteria, survival monitoring, and quality of life questionnaires. Researchers will also evaluate treatment responses, adverse events, and long-term outcomes up to nine years. The study involves scheduled follow-ups to monitor health and treatment effects throughout these phases.