Vicenza

This research is an international multicenter retrospective observational study focusing on patients with Essential Thrombocythemia ET who are positive for the JAK2V617F mutation. It aims to understand the progression from ET to Polycythemia Vera PV and compare clinical outcomes between those who progressed and those who did not, using criteria defined by the International consensus classification of myeloid neoplasms and acute leukemias from 2022. The study consists of two parts a nested case-control study and a comparative retrospective cohort study. The first part compares ET patients who progressed to PV with matched ET patients who did not progress, based on diagnosis year, age at diagnosis, and disease duration. The second part compares patients diagnosed with de novo PV without prior ET to the ET-to-PV cases, again matched by diagnosis year, age, and disease duration. All patients included in the study were diagnosed by the end of 2020 to allow at least 5 years of follow-up. Participants will have their medical histories reviewed retrospectively to analyze clinical data up to the baseline and at the time of progression. Researchers will assess phenotypic changes and clinical outcomes between groups, with no new treatments or interventions administered. The study is observational and aims to gather information from existing records to better understand disease evolution over time.

Primary immune thrombocytopenia ITP is a condition where the immune system mistakenly destroys platelets, leading to a lower number of platelets and increased risk of bruising or bleeding. This Phase 3 study evaluates the long-term safety, tolerability, and effectiveness of mezagitamab in adults with chronic primary ITP. The study also investigates how the body processes mezagitamab over an extended period. Participants who completed previous mezagitamab studies TAK-079-3002 or TAK-079-1004 will be invited to join this continuation trial. Eligible participants may receive mezagitamab injections on demand, with treatment courses repeated as needed based on specific criteria and the investigators clinical judgment. The treatment is administered subcutaneously. During the study, participants will visit the clinic several times for assessments. Researchers will monitor safety by tracking treatment-emergent adverse events, and evaluate effectiveness through platelet response and remission rates. Measurements of drug levels and antibodies will also be taken. The study may last up to approximately 108 weeks, allowing detailed long-term follow-up.

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 how well JNJ-79635322 works compared with an anti-B-cell maturation antigen BCMAxCD3 bispecific antibody in adults with relapsed or refractory multiple myeloma. This phase 3 study includes participants who have received at least three prior therapies and have progressive disease or insufficient response to their last treatment. The study aims to assess treatment outcomes including overall response and progression-free survival over a period of up to 5 years and 7 months. Participants are randomly assigned to receive either JNJ-79635322 or teclistamab, both given as subcutaneous injections. Treatment continues until disease progression or intolerable side effects occur. These two groups allow comparison of the effects of each drug on disease control and patient well-being during the study. During the study, participants undergo regular assessments to monitor their response to treatment, including laboratory tests to measure disease markers and evaluations of symptoms, functioning, and quality of life. Researchers will track adverse events, immune responses to the drugs, and long-term outcomes such as duration of response and overall survival. The total participation time can extend up to nearly 6 years, with ongoing monitoring of symptoms and quality of life throughout this period.

Researchers are evaluating the efficacy and safety of Kedrion Intravenous Immunoglobulin 10% IVIg 10% in adult patients with chronic primary immune thrombocytopenia ITP, a condition characterized by low platelet counts lasting more than 12 months. This phase 3 study aims to assess how well this treatment works and its tolerability in adults aged 18 to 70 years with chronic ITP. Participants will receive one course of Kedrion IVIg 10% at a dose of 2 gkg, administered intravenously over 2 days. This single-group interventional study involves only this treatment, with no placebo or comparator. The treatment is given once, and participants will be followed up to 30 days after administration to monitor response and safety. During the study, participants will undergo platelet count assessments and evaluations for response to treatment, including complete response and time to platelet count improvement. Researchers will also monitor regression of hemorrhages and assess safety and tolerability from the first day of treatment through the end of the 30-day study period. The primary outcome measure is the rate of subjects with a response by day 14 after treatment.

This observational study aims to describe the use of teclistamab and talquetamab in treating patients with relapsed or refractory multiple myeloma RRMM outside of clinical trial settings. It collects real-world data to better understand how these treatments are used and their outcomes in typical healthcare environments. The study enrolls participants who have received at least one dose of teclistamab or talquetamab outside clinical trials during specified time periods from before December 2022 through December 2025. No study interventions are administered instead, researchers analyze existing medical records to document treatment details and patient experiences with these therapies. Participants medical records are reviewed to capture baseline characteristics, response rates, time to response, duration of response, survival outcomes, safety management, and treatment use up to 40 months. The study focuses on collecting comprehensive retrospective data without requiring active treatment or additional procedures, providing insight into real-world treatment patterns and outcomes for RRMM patients.

Primary immune thrombocytopenia ITP is a condition where the immune system mistakenly destroys platelets, the cells responsible for blood clotting, resulting in increased bleeding and bruising. This trial evaluates whether mezagitamab given as a subcutaneous injection can effectively maintain stable platelet counts in adults with chronic ITP compared to a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial designed to assess both the efficacy and safety of mezagitamab in this population. Participants are randomly assigned to receive either mezagitamab or a matching placebo by subcutaneous injection once weekly. The treatment schedule consists of 8 weekly doses followed by an 8-week break, then another 8 weekly doses, totaling up to 6 months of treatment. Those who finish this trial or do not respond to treatment by week 16 may have the option to join a continuation study to receive open-label mezagitamab if eligible and if the site is open. During the study, participants will visit the clinic multiple times for treatment and monitoring. Researchers will measure platelet responses, symptom changes using patient questionnaires, bleeding events, and blood concentrations of mezagitamab. Safety assessments include monitoring for anti-drug antibodies and adverse events. The primary outcome is the percentage of participants with a durable platelet response up to week 24. The trial is expected to complete in March 2028.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early anti-tumor activity of new drugs or combinations given before and after surgery in adults with locally advanced resectable gastric, gastroesophageal junction GEJ, or esophageal adenocarcinoma who have not had prior treatment for this disease. This Phase II, open-label study includes multiple sub-studies to test different novel drug combinations in participants. Participants will be assigned to one of three sub-studies where they receive combinations of investigational drugs such as AZD0901, Rilvegostomig, Trastuzumab Deruxtecan T-DXd, and chemotherapy agents like 5-Fluorouracil 5-FU, Capecitabine, or FLOT chemotherapy. Treatment is given as neoadjuvant before surgery and adjuvant after surgery therapy, with Rilvegostomig continuing as monotherapy after these phases. Drugs are administered mainly by intravenous infusion, except for Capecitabine, which is given orally. Participants will be closely monitored throughout the study for side effects and response to treatment, including assessments of surgical success, tumor response, event-free survival, and overall survival up to 38 months. Regular evaluations include clinical exams, laboratory tests, and pharmacokinetic measurements to track drug levels and immune response. The study aims to gather comprehensive safety and effectiveness data during the treatment and follow-up periods.

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 studying revumenib, an oral drug, in people with relapsed or refractory acute leukemias, including those with specific genetic mutations like MLLKMT2A rearrangements and NPM1 mutations. The study aims to find the highest safe dose and the recommended dose for further studies, as well as to evaluate how well the drug works, its safety, and how well patients tolerate it. This trial includes both a Phase 1 dose-escalation part and a Phase 2 expansion part focused on different leukemia types. In Phase 1, participants receive oral revumenib in one of six groups based on other medications they may be taking, such as antifungal drugs or cobicistat. The study tests increasing doses to find the maximum tolerated dose and recommended dose for Phase 2. In Phase 2, participants are grouped into four cohorts based on their leukemia subtype and genetic mutations to assess the drugs effects and safety over time. Participants will be monitored closely with assessments including blood tests to measure drug levels, side effects, and responses like remission rates. The study tracks outcomes such as adverse events, transfusion independence, and survival over several years. Participants physical health and leukemia status will be regularly evaluated to understand the treatments impact and safety throughout the trial and follow-up periods.