Tonsberg

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Researchers are studying the effects of filgotinib in children and adolescents aged 8 to less than 18 years who have moderately to severely active ulcerative colitis UC. The study aims to evaluate how well filgotinib works, its safety, how well it is tolerated, and how the body processes the drug in this young population. About 80 participants will be enrolled, including at least 8 children aged 8 to less than 12 years. Participants will take filgotinib once daily in the morning, either with or without food, using age-appropriate tablets. Doses are designed to match the systemic exposure seen in adults treated with 200 mg daily. Participants will take the medication at home except for on-site dosing at Weeks 4, 10, and 22. Those not reaching remission or response by Week 10 will continue induction treatment until Week 22, after which lack of remission will lead to discontinuation. During the study, participants will be monitored regularly to assess the drugs effectiveness and safety. The primary measure is remission at Week 10, with further assessments continuing through Week 58 and Week 62 to evaluate longer-term safety and tolerability. The total study duration extends to the primary completion date in June 2028.

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.

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.

Researchers are evaluating nemtabrutinib compared with investigators choice of ibrutinib or acalabrutinib in adults with untreated chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study aims to assess whether nemtabrutinib is not worse than these comparators in terms of objective response rate and whether it can provide longer progression-free survival. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will receive either nemtabrutinib, ibrutinib, or acalabrutinib orally at specified doses until their disease progresses, unacceptable side effects occur, or other discontinuation criteria are met. The trial uses a parallel-group design where participants are randomly assigned to one of the treatment groups, and no masking is involved. Both treatment arms continue until progression or intolerance. During the study, participants will be monitored regularly up to about 33 months for response rate and up to about 104 months for progression-free survival and overall survival. Assessments include clinical evaluations, safety monitoring for adverse events, and duration of response measurements. The study tracks treatment tolerability, discontinuations due to adverse events, and overall outcomes to better understand the therapies effects in this patient population.

Researchers are evaluating elritercept for its ability to reduce the need for red blood cell RBC transfusions and its safety compared to epoetin alfa in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who require regular blood transfusions. The study aims to understand if elritercept improves tiredness, lowers transfusion burden, enhances quality of life, and elicits an immune response. Participants receive either elritercept or epoetin alfa injections. Elritercept is given as a subcutaneous injection starting at 3.75 mgkg every 4 weeks, with possible dose increases to 5.0 mgkg. Epoetin alfa is administered as a subcutaneous injection starting at 450 IUkg once weekly, with possible dose escalation up to 1050 IUkg. The study follows participants for approximately 5 years to monitor treatment effects and safety. During the trial, participants are regularly assessed for transfusion independence, hemoglobin levels, fatigue, quality of life, and hematological improvements. Researchers monitor blood samples for drug concentration and immune response. Safety is evaluated through medical history, lab tests, and adverse event tracking. The main outcome is the proportion of participants achieving RBC transfusion independence for at least 12 weeks during the first 24 weeks. The study uses questionnaires and clinical assessments to measure fatigue and quality of life.

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.

Amyotrophic lateral sclerosis ALS is a severe and fast-progressing nervous system disease with a typical survival time of about 2.5 years after diagnosis. Currently, Riluzole is the only treatment available, and the care for advanced ALS is very costly. Research suggests that increasing access to Nicotinamide Adenine Dinucleotide NAD and activating enzymes called sirtuins might slow disease progression. Nicotinamide riboside NR increases NAD, and Pterostilbene stimulates sirtuins. The study aims to evaluate whether a combination of NR and Pterostilbene can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. This extension study follows patients who completed the initial NO-ALS trial, where all participants receive the combination supplement EH301 Nicotinamide Riboside and Pterostilbene. It is an open-label study offering compassionate use and monitoring adverse events. The study will assess if this combination can reduce motor symptom progression, preserve lung function, and increase survival over a one-year follow-up. Participants who completed the original NO-ALS trial will be followed for one year with regular assessments. Researchers will monitor adverse events throughout this period and measure disease progression using the ALS Functional Rating Scale Revised and changes in vital lung capacity. The study aims to provide long-term safety and efficacy data while allowing continued access to the supplement. Total participation duration is one year from enrollment in the extension study.

Researchers are evaluating the use of high-intensity focused ultrasound HIFU as a focal treatment combined with active surveillance in men with localized intermediate-risk prostate cancer. This approach aims to reduce the need for radical treatment of the entire prostate, which often causes side effects like erectile dysfunction and urinary incontinence. The study compares outcomes with a historical group of patients who underwent active surveillance alone, seeking to determine if focal therapy can safely control cancer progression while minimizing side effects. Participants with MRI-visible tumors and specific intermediate-risk prostate cancer will receive focal HIFU treatment targeting the main tumor. This is a prospective, single-arm study where all enrolled patients receive the same focal therapy and are then followed closely. The study will compare results to a historical control group treated with active surveillance from 2009 to 2017. The goal is to see if focal treatment reduces the need for radical therapy and maintains good cancer control and quality of life. During the trial, participants will undergo regular MRI scans, biopsies, and clinical evaluations over 1 to 10 years. Researchers will monitor tumor status, need for additional treatments, survival outcomes, and side effects related to erectile function and continence. Patient-reported quality of life will also be assessed. The study plans to include 245 men aged 55 to 80 with specific cancer risk profiles and will follow them long-term to evaluate tumor control, functional results, and overall survival.

Researchers are evaluating a complex intervention to improve advance care planning ACP for severely ill elderly people living at home who are acutely admitted to hospital. This cluster randomized study involves twelve Norwegian geriatric hospital units and aims to enhance patient and family involvement in treatment decisions, improve quality of life, and support ethical and legal care planning. The project also explores barriers and facilitators to implementing ACP at clinical, health service, and governmental levels, including economic analyses. The intervention group receives a comprehensive support program that includes leadership commitment, training for staff, implementation teams, ACP coordinators, and practical tools such as guidelines and documentation templates. The control group receives no implementation support during the trial but will be offered the program afterward. The study period includes baseline, 9-month, and 18-month assessments for the intervention group and baseline and 18-month assessments for the control group. Participants will undergo questionnaires and interviews with patients, relatives, clinicians, and staff at multiple time points before, during, and after the implementation. Data from patient records and national health registers will be collected to assess the fidelity of ACP implementation, clinical outcomes, communication quality, and cost-effectiveness. The trial runs until December 2026 and includes various measures to evaluate the impact of the support program on ACP delivery and related outcomes.