Alessandria

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

Researchers are evaluating a chemo-free combination of rituximab and golcadomide (CC-99282) as a front-line treatment for older, frail patients newly diagnosed with diffuse large B-cell non-Hodgkin lymphoma (DLBCL). This phase II, multicenter study focuses on patients aged 80 or older who are considered frail based on a simplified geriatric assessment (sGA) and are not eligible for standard anthracycline-based chemotherapy. The study aims to assess the effectiveness of this treatment approach in this vulnerable population. Participants will receive an induction phase of up to six 28-day cycles consisting of golcadomide, rituximab, and dexamethasone only during the first cycle. Response to treatment will be evaluated after four and six cycles to identify patients who are responding. Those achieving at least a partial response will continue as planned, while non-responders will stop protocol treatment and switch to alternative regimens. After induction, involved site radiotherapy is permitted for PET-positive disease. Patients with at least partial response at the end of induction may then enter a consolidation phase with up to six additional 28-day cycles of golcadomide. Interim response checks during consolidation will identify disease progression, leading to treatment discontinuation if needed. Throughout the study, participants will undergo assessments including PET/CT or CT scans to evaluate disease and sarcopenia at baseline and end of treatment. Quality of life will be measured at study entry, during treatment, and follow-up. Follow-up visits will occur every three months for the first year and every six months in the second year, with a total follow-up duration of 24 months. Progression-free survival at 24 months is the primary outcome. Patients with disease progression will be considered treatment failures and followed for survival until study completion.

Researchers are conducting an international multicenter retrospective observational study to better understand the progression and clinical outcomes in patients with Essential Thrombocythemia (ET) who have the JAK2V617F mutation and later develop Polycythemia Vera (PV). The study follows updated 2022 diagnostic criteria for these myeloid blood disorders and includes two parts: a nested case-control study and a comparative retrospective cohort study. In the first part, patients who progressed from ET to PV by the end of 2020 are matched 1:1 with ET patients who have the same mutation but did not progress, based on year and age at ET diagnosis and disease duration. The second part compares patients with newly diagnosed PV who never had ET, matched similarly by year and age at diagnosis and disease duration, ensuring at least 5 years of follow-up for these patients. Participants' medical records will be reviewed retrospectively to compare clinical features and outcomes up to their baseline dates. The study aims to clarify phenotypic changes and clinical results in these patient groups. No interventions are administered, and the study focuses on analyzing existing data to assess progression and outcomes in these blood conditions.

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 treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the effects of filgotinib in children and adolescents aged 8 to less than 18 years with moderately to severely active ulcerative colitis (UC). The study aims to assess the drug's efficacy, safety, tolerability, and how the body processes the medication. About 80 participants, including at least 8 children aged 8 to under 12, will take part in this Phase 3 trial. Participants will receive filgotinib orally once daily in the morning, with or without food. The study drug is provided as film-coated tablets in doses appropriate for pediatric use, aiming for the same exposure level as adults receiving 200 mg daily. Participants will take the study drug at home on most days, but will take it under supervision at the study site during visits at Weeks 4, 10, and 22. Those not achieving remission or response by Week 10 will continue treatment until Week 22, after which those who still do not reach remission will stop treatment. During the study, participants will be closely monitored for treatment effects and safety. Researchers will assess remission and response at Weeks 10 and 58. Evaluations include clinical scoring of disease activity and safety assessments throughout the trial. Total participation duration and detailed monitoring plans are designed to understand both the short- and longer-term effects of filgotinib in this young population.

Researchers are evaluating the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.

The trial investigates the progression-free survival benefit of duvelisib monotherapy compared to the investigator's choice of gemcitabine or bendamustine in adults with relapsed or refractory nodal T cell lymphoma exhibiting the T follicular helper (TFH) phenotype. This phase 3, open-label, randomized controlled study focuses on participants whose disease has returned or not responded after at least one prior systemic cytotoxic therapy and who have measurable disease according to established criteria. Participants will be assigned to receive either oral duvelisib capsules or an intravenous solution of gemcitabine or bendamustine, based on investigator choice. The study treatments are given as monotherapy. The trial is multicenter and open-label, meaning both participants and researchers know which treatment is being given. Throughout the study, participants will be monitored for progression-free survival, as evaluated by an Independent Review Committee, for up to three years. Researchers will assess disease status and treatment effects using standardized criteria. Safety and treatment adherence will also be observed during the study period.

Researchers are evaluating the effects of guselkumab, a medication targeting the IL-23 pathway, in children aged 2 to 17 years with moderately to severely active Crohn's Disease. This Phase 3 study aims to assess both clinical and endoscopic improvement by the end of one year of treatment, focusing on participants who responded to guselkumab after 12 weeks. Participants receive guselkumab either as an injection under the skin or through an intravenous infusion. The study measures effectiveness at Week 52, following initial response at Week 12, to determine remission rates and healing observed via endoscopy. Throughout the study, children will be closely monitored with clinical assessments, endoscopic exams, and evaluation of disease activity scores. Researchers will track safety and treatment response over the 52-week period to understand guselkumab's role in managing pediatric Crohn's Disease.