Limerick

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Researchers are evaluating the care provided by the Geriatric Emergency Medicine Unit GEM-U for older adults aged 75 years and older attending the emergency department. This study aims to understand how this specialized, holistic care impacts important health outcomes such as hospital admission rates, function, quality of life, and healthcare usage. The study focuses on frail older adults who require comprehensive, person-centered care due to complex health issues. The GEM-U delivers care through a team approach using comprehensive geriatric assessment by multiple healthcare disciplines. Participants will be monitored over time with follow-ups at 30 days and 6 months after their initial GEM-U visit. The study will collect data on clinical and process outcomes including measures of function, delirium, frailty, nutrition, quality of life, and patient satisfaction. During the study, participants will complete various assessments such as the Barthel Index for function, delirium screening, Clinical Frailty Scale, Mini Nutritional Assessment, EuroQoL-5D-5L quality of life questionnaire, and a patient satisfaction survey PSQ-18. Researchers will track hospital admissions, mortality, emergency visits, nursing home admissions, and healthcare use at 30 days and 6 months. All participants provide informed consent and data will be analyzed following standardized reporting guidelines.

Researchers are evaluating elritercept TAK-226, KER-050, an investigational drug, for treating anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who need regular red blood cell RBC transfusions. The study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to assess how well elritercept reduces the need for RBC transfusions and to evaluate its safety and tolerability over time. Participants will be randomly assigned in a 21 ratio to receive either elritercept or a matching placebo, both given as subcutaneous injections 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 their assigned treatments. Eligible participants may also enter an Extension Phase to continue treatment until individual discontinuation or study unblinding. After treatment ends, a Safety Follow-Up Period of 8 weeks and a long-term follow-up lasting up to 5 years will monitor participants. During the study, participants will have visits approximately every 2 weeks initially, then every 4 weeks, to assess treatment effects and safety. Researchers will evaluate the percentage of participants achieving transfusion independence and monitor adverse events, laboratory values, vital signs, and heart tests. Long-term follow-up will continue through regular check-ins for up to five years or until the participant withdraws or the study ends.

This trial investigates the effectiveness and safety of two treatment combinations for people with relapsed or refractory multiple myeloma who have received one to three prior treatments and were previously treated with lenalidomide. It compares mezigdomide, bortezomib, and dexamethasone MeziVd against pomalidomide, bortezomib, and dexamethasone PVd to see which is better for this condition. The study is a Phase 3, randomized, open-label trial sponsored by Celgene. Participants receive either the MeziVd combination or the PVd combination, with specified doses given on certain days according to the study plan. These treatments are given as drugs, and participants are randomly assigned to one of these two groups to compare their effects. The study will continue for up to approximately five years to evaluate long-term outcomes. During the study, participants will be monitored regularly through various assessments including measuring disease progression, survival, response to treatment, and quality of life using specific questionnaires EORTC QLQ-C30 and QLQ-MY20. Blood samples may be checked for drug levels, and adverse events will be tracked. The main focus is progression-free survival, measured from randomization until disease worsening or death. Participants health and responses will be followed for up to five years, with ongoing visits and evaluations throughout this period.

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with either obinutuzumab or rituximab compared to venetoclax plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This Phase 3 randomized study aims to understand which combination offers better progression-free survival and treatment outcomes in patients who have undergone prior therapies. The study has four treatment groups sonrotoclax combined with obinutuzumab, sonrotoclax combined with rituximab, sonrotoclax plus obinutuzumab with treatment guided by minimal residual disease evaluation, and venetoclax combined with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are administered intravenously. Participants receive these treatments according to their assigned group as part of this clinical research. Participants will be monitored for progression-free survival, overall survival, response rates, and minimal residual disease status over several months up to several years. Safety assessments include tracking treatment-emergent adverse events. Quality of life and symptom burden will be evaluated using questionnaires. The study involves regular visits for treatment administration and assessments, with follow-up extending up to 84 months to observe long-term outcomes.

Researchers are studying an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. The study aims to compare the effects and safety of linvoseltamab combined with standard treatment against the standard treatment alone. This is a Phase 3 randomized, open-label trial sponsored by the European Myeloma Network B.V. Participants will receive either the combination of daratumumab, lenalidomide, dexamethasone, and linvoseltamab or continued treatment with daratumumab, lenalidomide, and dexamethasone alone. Treatments will be given according to the study protocol, and participants will be randomly assigned to one of these two groups. The study will continue for up to 11 years to assess long-term effects. During the study, participants will undergo various assessments including measurements of minimal residual disease MRD, progression-free survival, overall survival, and response rates. Quality of life will also be evaluated using standardized questionnaires. Safety will be closely monitored by tracking adverse events and laboratory tests. Participants will be followed up for up to 11 years, with regular visits to assess disease status and treatment impact.

Researchers are evaluating two types of stereotactic body radiotherapy SBRT in men with high risk localized prostate cancer, where the cancer is confined to the prostate but may grow quickly or spread. The study aims to compare the safety and effectiveness of delivering radiotherapy to the prostate alone versus the prostate plus surrounding lymph nodes, with both treatments given in only 5 sessions. This phase III trial is designed to see if including lymph nodes reduces the chance of cancer returning and to review any side effects that occur. Participants will be randomly assigned to one of two groups. One group will receive SBRT targeting the prostate and seminal vesicles, delivering 36.25Gy in 5 fractions on alternate days with 40Gy to the prostate clinical target volume. The other group will get the same prostate treatment plus 25Gy in 5 fractions to the pelvic lymph nodes on alternate days. Treatments will be provided over approximately two weeks at experienced NHS radiotherapy centers that meet quality standards for these therapies. During the study, participants will be monitored for at least three and a half years to assess time to biochemical or clinical failure, which is the main outcome. Researchers will also track acute and late side effects, cancer relapse, survival rates, patient-reported outcomes, and adherence to treatment protocols for up to five years post-randomization. Regular imaging and assessments will be performed before treatment to confirm eligibility and exclude metastatic disease. Overall, participants can expect close monitoring and follow-up throughout and after their treatment period.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

Researchers are investigating the proteomic and molecular features of primary and recurrent or metastatic breast tumors. The study particularly focuses on the expression of S100 protein and the estrogen receptor ER, progesterone receptor PR, and HER2 genes. The aim is to deepen understanding of the molecular pathways that drive breast cancer progression and how these pathways respond to different treatments. The research also seeks to link proteomic results with survival data and to find potential blood markers that could indicate breast cancer progression. Participants will undergo standard treatment while tissue and blood samples are collected at various times. Tissue samples, both fresh frozen and formalin-fixed paraffin-embedded, will be taken during surgery or biopsy of primary or recurrentmetastatic tumors. Blood samples will be collected before neoadjuvant treatment if applicable, and before and after surgery or biopsy. For recurrent or metastatic cases without surgery, blood will be drawn before starting treatment. Additional blood samples will be taken annually for up to five years in primary cases and up to two years in recurrent or metastatic cases. Throughout the study, clinical data will be gathered alongside the biological samples to support the research. The primary outcome measure is the investigation of proteins and their pathways in primary breast cancer over ten years. Secondary outcomes include comparing molecular profiles between primary and recurrentmetastatic tumors, identifying new molecular mechanisms of recurrence, and finding potential targets for treatment. Participants will be followed and evaluated over the long term to support these research goals.

Researchers are studying community-based exercise programs tailored for older adults with chronic musculoskeletal pain in Ireland. This study aims to address the lack of resources in chronic pain management by evaluating whether specialized exercise classes, led by trainers educated in pain neuroscience, can help reduce the need for secondary healthcare. The trial also explores how exercise can be adapted to support people with chronic pain, considering their unique challenges and fears of symptom worsening. The study involves trained exercise trainers leading weekly classes for 8 weeks, offering activities such as Tai Chi, Activator Pole walking, Aquarobics, yoga, Pilates, or circuit-style fitness. Participants in the intervention group receive these classes plus a paper-based education manual on physical activity and pain management based on Explain Pain principles. The control group receives only the education manual and continues usual care but will be offered the exercise classes after completing follow-up assessments. Participants will be engaged through regular assessments including pain intensity, function, emotional health, satisfaction, physical activity levels, and quality of life before and after the 8-week intervention. Researchers will monitor recruitment, retention, refusal, and attendance rates throughout the study. The trial lasts 8 weeks with follow-ups to assess the impact of tailored exercise on chronic pain management and participants wellbeing.