Tonsberg

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

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.

This research focuses on patients with Relapsed/Refractory Multiple Myeloma (RRMM) who have been treated with the T-cell redirectors teclistamab or talquetamab outside of clinical trials. The study aims to describe the clinical outcomes and safety management of these treatments in a real-world setting, analyzing how patients respond and survive after receiving these therapies. The study does not administer any new interventions but instead collects and analyzes retrospective data from medical records of patients who have received teclistamab or talquetamab. Participants are grouped based on when they received their first dose, covering different time periods up to the end of 2025. This allows the study to assess outcomes for patients treated with these drugs over several years. Throughout the study, researchers will monitor various outcomes, including overall response rates, time to response, duration of response, minimal residual disease status, overall survival, progression-free survival, and time to next treatment. Safety management during treatment is also described. Data will be collected from baseline (day 1) through up to 40 months following treatment initiation, using medical records to understand treatment effects and patient characteristics over time.

Immunoglobulin A nephropathy (IgAN) is a kidney disease caused by the build-up of immune protein complexes in the kidneys, leading to inflammation and possible kidney damage. This Phase 3 study is evaluating how well mezagitamab, compared to a placebo, reduces protein levels in the urine (proteinuria) in adults with primary IgAN. It also aims to assess the safety and tolerability of mezagitamab and its ability to maintain kidney function over the long term. Participants will be randomly assigned to one of two groups in the main study: two-thirds will receive mezagitamab injections under the skin, and one-third will receive placebo injections that look identical but have no active medicine. Treatment will occur in two 1-year cycles, each including about six months of dosing and six months of observation with monthly check-ups. An open-label group will include a small number of participants with lower proteinuria or kidney filtering issues, including those who previously received mezagitamab in another study; these participants will receive mezagitamab similarly to the main group. During the study, participants will visit the clinic several times for assessments. Researchers will monitor changes in proteinuria from the start through week 36, along with safety and kidney function. They will also perform regular evaluations and check-ups throughout each treatment and observation period to track participants' health and response to treatment.

Researchers are evaluating nemtabrutinib compared with the investigator's choice of ibrutinib or acalabrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received any prior therapy. This Phase 3 study aims to determine if nemtabrutinib is not worse than ibrutinib or acalabrutinib in terms of objective response rate and if it is better regarding progression-free survival, both assessed using standardized disease criteria by independent review. Participants will be randomly assigned to receive one of the three oral treatments: nemtabrutinib, ibrutinib, or acalabrutinib. The study compares the effectiveness of nemtabrutinib against the other two drugs chosen by the investigator to treat first-line CLL/SLL. Treatment continues with monitoring over months to assess response and disease progression. During the study, participants will undergo evaluations based on the International Workshop on Chronic Lymphocytic Leukemia criteria, including blinded independent central reviews of their disease status. Researchers will track objective response rates up to about 33 months and progression-free survival up to around 104 months. Participants will also be monitored for safety and treatment adherence throughout the trial period.

Researchers are evaluating how well elritercept works compared to epoetin alfa in treating anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to see if elritercept can reduce the need for RBC transfusions, improve tiredness without transfusions, lower transfusion burden, and enhance quality of life. It also examines the immune response to elritercept and monitors its safety. Participants receive either elritercept or epoetin alfa as subcutaneous injections. The study is a phase 3, multicenter, randomized trial comparing the efficacy and safety of these two drugs. The treatment period lasts through 24 weeks, with each cycle lasting 28 days. Researchers monitor participants for RBC transfusion independence lasting at least 12 weeks and a significant increase in hemoglobin levels. During the study, participants undergo regular assessments including blood tests to measure hemoglobin and other blood counts. Researchers track transfusion needs and quality of life reports. Safety is carefully monitored throughout the trial. Participants are involved from screening through 24 weeks of treatment, with evaluations to measure the effectiveness of the treatments and any side effects.

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.

Amyotrophic lateral sclerosis (ALS) is a serious, fast-progressing nervous system disease with an average survival of 2.5 years after diagnosis. Currently, effective treatments are limited to Riluzole. Research suggests that increasing cell access to Nicotinamide Adenine Dinucleotide (NAD) and stimulating enzymes called sirtuins may slow disease progression. This study aims to evaluate whether a combination of Nicotinamide Riboside (NR) and Pterostilbene, called EH301, can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. The NO-ALS extension study follows patients who completed the original NO-ALS trial. All participants receive the active treatment EH301, which combines Nicotinamide Riboside and Pterostilbene, as an open-label extension. This study provides patients the option for compassionate use of the supplement while assessing its effects on motor symptoms, lung function, and survival. Participants will be monitored for adverse events throughout the study, which lasts up to 1 year. Researchers will track safety, progression of motor symptoms, changes in vital capacity, and overall survival. This extension allows long-term observation of EH301's impact on ALS progression and patient well-being.

Researchers are evaluating the use of high-intensity focused ultrasound (HIFU) as a focal treatment combined with active surveillance for men with intermediate-risk localized prostate cancer. The study aims to determine if this approach can reduce the need for radical treatment, which often has significant side effects like erectile dysfunction and urinary incontinence, while maintaining good cancer control and survival outcomes. The trial compares results from patients receiving HIFU to historical controls who underwent active surveillance alone. Participants will receive focal HIFU treatment targeting the MRI-visible index tumor. This procedure is designed to eradicate the tumor while preserving prostate tissue to minimize side effects. After treatment, patients will continue with MRI-supplemented active surveillance to monitor for tumor progression. The study is prospective and single-arm, with historical controls used for comparison. Recruitment primarily takes place at Vestfold-Telemark County, with possible participation from other Norwegian institutions. During the study, patients will undergo regular biopsies and MRI scans to assess tumor status and treatment effects. Researchers will track outcomes including tumor eradication rates, need for repeat or radical treatment, survival measures, and functional results like erectile and urinary function over 1 to 10 years. Quality of life and the ability of MRI to predict biopsy results are also evaluated. The total follow-up aims to provide long-term data on the safety and effectiveness of this treatment approach.

Researchers are evaluating a complex intervention aimed at implementing advance care planning (ACP) for severely ill elderly patients who live at home and are acutely admitted to hospital. The study uses a cluster randomized design involving twelve Norwegian hospital units specializing in geriatric care. It seeks to understand current ACP implementation, identify barriers and facilitators at multiple levels, explore ethical dilemmas, and assess the benefits and challenges experienced by patients, relatives, and healthcare staff. The project also aims to measure the impact of an implementation support program on communication quality, decision-making, and healthcare outcomes, as well as its cost-effectiveness. The intervention includes a comprehensive implementation support program featuring leadership commitment, responsive evaluation, a whole ward approach, and a train-the-trainer model to ensure sustainability. This program provides an implementation team and ACP coordinators, along with training, supervision, network conferences, and shared resources such as guidelines and teaching materials. The clinical intervention involves routine information and invitation to ACP for eligible patients, written materials for patients and relatives, and documentation with collaboration across healthcare levels. Half of the hospital units receive this support immediately, while the others receive it after the intervention period. Participants are involved through questionnaires to staff, clinicians, patients, and relatives, as well as patient record reviews and qualitative interviews. The study measures fidelity to the ACP model at multiple time points and evaluates patient-reported, relative-reported, and clinician outcomes during the intervention period, which spans 10 to 18 months after starting the support. Researchers also assess barriers and facilitators in wider healthcare contexts and perform economic analyses. The total involvement includes baseline and follow-up assessments up to 18 months.