Civitanova Marche

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include 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 incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating the effectiveness, safety, and patient-reported outcomes of standard treatments for people with relapsed or refractory multiple myeloma in real-world clinical settings. This study follows participants over 24 months to observe how current standard care works for those who have previously received treatment for this condition. The research includes participants who meet specific diagnostic criteria and have measurable disease based on recognized myeloma guidelines. The study does not involve any experimental treatment; instead, it observes patients receiving standard care as decided by their doctors. Participants include those who have undergone multiple prior therapies, including specific drug classes and targeted treatments, depending on the study period. The study covers different periods with slightly varied eligibility and treatment histories, including a group starting talquetamab treatment for relapsed or refractory multiple myeloma. Participants will be monitored for up to 52 months to evaluate their response to treatment, including overall response rates. Researchers will collect data on their health status, treatment history, and patient-reported outcomes. Safety and effectiveness will be assessed based on clinical evaluations and disease progression as determined by their healthcare providers throughout the study period.

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 conducting an observational, non-interventional, multicenter study to prospectively collect, store, and analyze biological samples from patients with conditions including Multiple Myeloma, Smoldering Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Myeloma, and MGUS. The study aims to establish a common international infrastructure for gathering standard clinical information at the start and during treatment while uniformly collecting and storing biological samples. The main intervention involves the collection and storage of biological samples from participants. The study does not involve treatment but focuses on creating a biobank that can be used for long-term research purposes, with sample storage planned for up to 30 years. Participants will provide written informed consent and contribute biological samples and clinical data. Researchers will monitor compliance with study requirements and follow-up schedules. The primary outcome is the establishment and maintenance of a biobank over a long-term period, supporting future research and analysis.

This research investigates Diffuse Large B-cell Lymphoma (DLBCL) and High-Grade B-cell Lymphoma (HGBCL), which are diverse types of lymphomas affecting adults. The study aims to understand how genetic changes in the MYC gene relate to the lymphoma's genetic makeup and immune environment, and how these factors might influence patient outcomes. It focuses especially on MYC rearrangements and gain of copy number (GCN), which may affect prognosis and response to treatment. Participants in this observational study include patients diagnosed with nodal or extranodal DLBCL or HGBCL, including certain subtypes like double and triple hit lymphomas. The research examines patients who have received curative first-line treatments such as R-CHOP or intensified chemotherapy regimens. The study involves reviewing histological samples, including immunohistochemistry and genetic analyses, to explore the relationship between MYC alterations and lymphoma characteristics. During the study, researchers evaluate clinical, genetic, and histopathological features from diagnosis through up to 36 months of follow-up. Detailed tissue analysis and genetic testing are performed to assess MYC rearrangements or GCN. The study also looks at the lymphoma's immune environment and tracks patient outcomes to identify correlations that could improve prognostic markers and treatment strategies.

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.