Civitanova Marche

Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies MAB in patients with B-cell Non-Hodgkin Lymphoma NHL treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as 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 the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.

This research aims to observe the real-life effectiveness, safety, and patient-reported outcomes of standard antimyeloma treatments in adults with previously treated relapsed andor refractory multiple myeloma over a 24-month period. The study focuses on participants receiving routine care for this condition as part of their regular medical treatment. Participants with relapsed or refractory multiple myeloma undergoing standard antimyeloma treatments in routine clinical practice will be observed. There is no investigational treatment administered by the study instead, medical records will be the primary data source to track treatments and outcomes during the study. During the study, participants medical records will be reviewed to assess response rates, survival, disease progression, quality of life, and adverse events over up to 52 months. Patient health and well-being will be monitored using standardized questionnaires, and safety will be evaluated through reported side effects. The overall involvement includes observation and data collection without changing the participants treatment plans.

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.

The study focuses on patients with various conditions related to plasma cells, including Monoclonal Gammopathy of Undetermined Significance MGUS, smoldering Multiple Myeloma SMM, Multiple Myeloma MM, and Plasma Cell Leukemia PCL. It is an observational, non-interventional, multicenter research project aimed at collecting, storing, and analyzing biological samples from these patients. The purpose is to create an international infrastructure for gathering consistent clinical data and biological samples at different stages of disease and treatment. Participants provide biological samples such as bone marrow aspirate, bone marrow biopsy, extramedullary disease EMD biopsy, peripheral blood, and serum at multiple timepoints. These include baseline, pre-maintenance or after one year of therapy depending on transplant eligibility, during maintenance therapy if part of standard care, and at first or later progression of disease. The study collects and stores these samples over a long period to support future research. Participants will undergo sample collections at scheduled times during their disease course and treatment phases. Researchers will monitor and analyze the stored biological samples and clinical data to support a biobank lasting up to 30 years. The study does not involve any experimental treatments but focuses on gathering data and samples to better understand the conditions. Participation requires written informed consent and compliance with the protocols follow-up schedule.

Researchers are investigating the relationship between MYC gene changes, lymphoma genetic mutations, and the immune environment in adults with Diffuse Large B-cell Lymphoma DLBCL or High-Grade B-cell Lymphoma HGBCL. These lymphomas are diverse diseases making up over a third of adult lymphomas, with survival rates of around 60-70% over five years. The study aims to better understand these genetic factors and their impact on disease outcomes to improve treatment approaches. This observational study includes patients diagnosed with DLBCL or HGBCL who have MYC gene rearrangements or increased MYC gene copies. Participants have received standard first-line chemotherapy treatments such as R-CHOP or intensified regimens. The study collects data retrospectively and prospectively to explore genetic markers, immune cell patterns, and clinical outcomes related to these MYC changes and other genetic alterations. Participants provide tissue samples and clinical information, which researchers analyze for genetic and histological features. The study evaluates how these factors relate to patient responses and survival over up to 36 months. Researchers also review treatment types, risk of disease recurrence, and the effectiveness of preventive therapies. The study spans from diagnosis after January 2019 through long-term follow-up, helping to identify potential prognostic and predictive markers in lymphoma.

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 a new treatment approach for adults with newly diagnosed Acute Myeloid Leukemia AML who have mutations in the NPM1 or KMT2A genes and are not eligible for intensive chemotherapy. The study focuses on adding revumenib, a drug that blocks a molecule called menin important for leukemia cell survival, to standard treatment with azacitidine and venetoclax. This is a randomized, double-blind, placebo-controlled Phase 3 clinical trial aiming to improve outcomes for these patients. Participants will receive either revumenib or a placebo alongside azacitidine and venetoclax in continuous 28-day treatment cycles. Treatment continues until disease progression, unacceptable side effects, death, withdrawal, or other protocol-defined reasons for stopping. After the last patient is enrolled, there will be a 4-year follow-up period to observe survival and ongoing health. During the study, patients will be closely monitored with regular assessments to track overall survival, rates and duration of remission, event-free survival, and quality of life. Genetic and molecular tests will evaluate response at the bone marrow and blood levels. Safety and tolerability will also be monitored throughout treatment and the follow-up phase, which together may last several years.