Limerick

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 studying older adults aged 75 years and older who use the Geriatric Emergency Medicine Unit (GEM-U), a specialized care unit within the emergency department aimed at providing comprehensive, person-centered care for frail older patients. The study seeks to understand how this specialist care affects various health outcomes, including physical function, quality of life, and healthcare use such as hospital admissions. The GEM-U delivers care through a team approach using comprehensive geriatric assessments. The study will observe patients who meet certain risk criteria and have medical conditions requiring assessment by the Older Persons Integrated Care Team. Participants will be followed for 30 days and again at 6 months after their initial emergency department visit to evaluate clinical and process outcomes. During the study, researchers will collect information through patient-reported measures including functional status, delirium screening, frailty, nutritional status, quality of life, and patient satisfaction. The main outcome measured is the rate of hospital admissions following the initial GEM-U visit. Data will be analyzed following established reporting guidelines to better understand the impact of this specialized care on older adults' health and wellbeing.

Researchers are evaluating faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. The study, called FaReal, aims to assess the effectiveness, safety, clinical insights, and treatment patterns of faricimab in real-world routine clinical practice over a two-year follow-up period. It also seeks to describe and evaluate health economic aspects related to prior anti-VEGF treatments and current faricimab therapy. Faricimab will be given following local clinical practice and labeling guidelines. Patients must have started faricimab treatment at or within three months before signing consent and have received at least one dose in the study eye. The study does not specify fixed dosing schedules but observes real-world use over time. Participants will have data collected on visual acuity and central subfield thickness at baseline and throughout the study. The main outcome measure is the change in visual acuity from the start date to 12 months. Data on treatment safety, clinical practice insights, and health economic factors will also be gathered. The total follow-up period for patients is two years, allowing for long-term monitoring of treatment effects and safety.

Researchers are evaluating how well elritercept (TAK-226, KER-050) works in reducing the need for red blood cell (RBC) transfusions in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require regular blood transfusions. The study is a Phase 3, double-blind, randomized, placebo-controlled trial that also aims to assess the safety and tolerability of elritercept over both short and longer periods, including in adults with high transfusion needs. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept or a matching placebo by subcutaneous injection every 4 weeks. The study includes a Primary Phase lasting 24 weeks and a Secondary Phase lasting an additional 24 weeks, during which participants continue the same treatment. Following these phases, an Extension Phase allows eligible participants to continue treatment until discontinuation or study unblinding. Study visits occur every 2 weeks during the first 6 cycles and every 4 weeks thereafter. Treatment continuation depends on meeting disease assessment criteria every 24 weeks. Participants will undergo various assessments including bone marrow aspirates, transfusion evaluations, and disease status checks throughout the study. Safety follow-up lasts for 8 weeks after the last dose, with visits every 4 weeks during this time. Afterward, long-term follow-up occurs quarterly for up to 5 years or until withdrawal, death, loss to follow-up, or study closure. The main outcome measured is the percentage of participants achieving transfusion independence for at least 8 weeks during the first 24 weeks of treatment.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the effectiveness and safety of a new drug combination called Mezigdomide (CC-92480) with bortezomib and dexamethasone (MeziVd) compared to an existing combination of pomalidomide, bortezomib, and dexamethasone (PVd). This study focuses on adults with relapsed or refractory multiple myeloma (RRMM) who have previously received between one and three lines of therapy, including prior lenalidomide treatment. The trial is a Phase 3, randomized, multicenter, open-label study aiming to improve outcomes for this condition. Participants will be assigned to receive either the MeziVd or PVd treatment regimen, with specified doses of each drug given on certain days. The study involves two treatment groups: one receiving mezigdomide, bortezomib, and dexamethasone, and the other receiving pomalidomide, bortezomib, and dexamethasone. Both regimens follow precise dosing schedules as determined by the study protocol. During the study, participants will be monitored regularly for disease progression or death, with the primary outcome being progression-free survival over up to approximately five years from the date of randomization. Ongoing assessments will include evaluations of safety and effectiveness. The total participation time may vary, and researchers will closely follow participants to gather detailed information on treatment responses and adverse effects.

Researchers are evaluating how well sonrotoclax combined with obinutuzumab or rituximab compares to venetoclax plus rituximab in treating adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 3, open-label study will also assess the safety of these treatment combinations. The study is sponsored by BeOne Medicines, previously known as BeiGene, and involves multiple centers. Participants will receive one of the following treatments: sonrotoclax taken orally with intravenous obinutuzumab, sonrotoclax taken orally with intravenous rituximab, or venetoclax taken orally with intravenous rituximab. The treatments are given according to the study protocol, and participants are randomly assigned to one of these groups. The study monitors how these combinations work over time. During the study, participants will be regularly assessed through evaluations such as imaging, laboratory tests, and physical exams to monitor disease progression and treatment effects. Researchers will measure progression-free survival, which is how long participants live without disease worsening, with follow-up lasting up to about 51 months. Safety is also closely monitored to understand any side effects. The total duration of participation depends on the individual treatment and follow-up schedules.

Researchers are evaluating an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplantation. The study focuses on comparing the effects and safety of linvoseltamab against the standard treatment in this group of patients. This is a Phase 3 randomized, open-label study involving transplant-ineligible multiple myeloma patients. Participants will receive either linvoseltamab according to the study protocol or a combination of daratumumab, lenalidomide, and dexamethasone as the standard treatment. The trial includes an induction phase with daratumumab, lenalidomide, and dexamethasone followed by treatment with linvoseltamab or continuation of the standard therapy. All drugs are administered as directed by the study protocol. During the study, participants will be closely monitored for disease response and safety over a period of up to 11 years. Researchers will measure outcomes such as minimal residual disease status, progression-free survival based on specific criteria, and treatment response assessed by blinded independent review. Safety and long-term effects will also be evaluated throughout the study duration.

Researchers are evaluating the safety and effectiveness of advanced external beam radiotherapy called stereotactic body radiotherapy (SBRT) in men with high risk localized prostate cancer. This cancer is limited to the prostate but has a high chance of growing quickly or spreading. The study compares SBRT given to the prostate alone versus SBRT given to both the prostate and surrounding lymph nodes. It is a Phase III trial involving 1128 participants to see which treatment option is better and safer over at least three and a half years of follow-up. Participants receive radiotherapy in 5 visits over two weeks. Half of the men will have SBRT targeted only to the prostate, while the other half will have it directed to both the prostate and pelvic lymph nodes. The treatments are delivered at NHS radiotherapy centers experienced with SBRT and pelvic node radiotherapy. Quality assurance ensures the treatments are administered properly. During the study, men will undergo scans including multi-parametric MRI and various types of PET-CT or MRI to stage their cancer before treatment. Researchers will monitor side effects and cancer outcomes to assess safety and effectiveness. The main outcome measured is the time until biochemical or clinical failure, with a minimum follow-up of 3.5 years after randomization. Participants will be closely followed for side effects and cancer control throughout the study period.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.