Rionero In Vulture

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.

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 evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Researchers are collecting epidemiological data on adults newly diagnosed with myelodysplastic syndrome MDS through a regional network of registries in Italy. The study aims to use a standardized electronic case report form to gather and anonymously share data across regions and with other international MDS registries. This observational study helps better understand the incidence, prevalence, and progression of MDS over time. Participants are adults diagnosed with MDS who consent to share their medical data. The study does not involve any treatment or intervention but focuses on data collection and monitoring through regional registries. The network facilitates aggregation and analysis of anonymous epidemiological information to support research and improve knowledge on MDS. During the study, researchers will track key outcomes over six years, including new MDS diagnoses, response rates, prevalence, overall survival, progression-free survival, and progression to acute myeloid leukemia AML. Participants information will be collected and stored securely without altering standard medical care. The study is expected to continue until May 2032, with ongoing data collection and long-term follow-up.

Researchers are observing adult male patients with metastatic castration resistant prostate cancer mCRPC who are treated with lutetium 177Lu vipivotide tetraxetan. This non-interventional, prospective, multicenter study aims to describe routine clinical practice and gather real-world data on this treatment. The study will follow patients for a maximum of 18 months after their treatment ends. The study includes patients who have been prescribed lutetium 177Lu vipivotide tetraxetan by their treating physician team. There are no additional experimental treatments or interventions, as this is an observational study. The observation period covers from the start of treatment up to 18 months post-treatment, including monitoring during the treatment duration. Participants will be monitored through regular clinical assessments and data collection on outcomes such as progression-free survival, overall survival, prostate-specific antigen response, pain medication use, and quality of life measures. Researchers will also track hospitalizations related to the treatment, dosimetry, number of visits, and workdays lost. The total involvement for each participant can last up to 18 months after treatment completion.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.

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.

Oligometastatic breast cancer occurs when breast cancer has spread to a limited number of other body sites. Patients with this condition may live longer than those with more widespread metastases. Researchers are investigating whether adding local treatments like stereotactic body radiotherapy SBRT, a non-invasive radiation therapy delivering high doses in a few sessions, can improve disease control and survival in these patients. This study is a multicenter retrospective analysis aiming to better understand SBRTs role in this setting. The study focuses on patients who have received SBRT to their oligometastatic sites, delivering a minimum radiation dose of 50 Gy EQD2 in up to 12 sessions, following the Oligocare definition. This local treatment is considered alongside standard systemic therapies like chemotherapy or hormonal therapy. The study collects data from treatments performed between January 2010 and December 2023 to evaluate outcomes. Participants data will be reviewed retrospectively to measure progression-free survival as the primary outcome. Secondary outcomes include local control of treated sites, overall survival, and acute or late radiation-related toxicities. The study covers treatments applied outside the brain and aims to provide insights into the safety and effectiveness of SBRT in managing oligometastatic breast cancer. The overall participation involves analysis of existing patient records from multiple centers up to the end of 2023.