Zielona Gora

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating VENT-03 in adults with active cutaneous lupus erythematosus CLE, including those who may also have systemic lupus erythematosus SLE. This Phase 2a clinical trial aims to determine if VENT-03 affects the activity and severity of CLE and to assess its safety and how the body processes the drug. Participants will be compared to a placebo group to better understand VENT-03s effects. Participants will take either VENT-03 tablets or a placebo for the first 4 weeks. After this double-blind phase, all participants switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study uses a randomized, double-blind design with monthly clinic visits for checkups and tests throughout the treatment periods. During the study, participants will visit the clinic once a month for assessments including physical exams and tests to monitor the drugs effects and safety. Researchers will evaluate changes in interferon gene signature in the skin, CLE disease severity, skin biopsy markers, and record any treatment-emergent adverse events. Blood samples will be collected to study the drugs concentration over time. The total treatment duration is 12 weeks with ongoing safety and efficacy monitoring.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations teclistamab with daratumumab and lenalidomide Tec-DR, and talquetamab with daratumumab and lenalidomide Tal-DR, against the standard treatment of daratumumab, lenalidomide, and dexamethasone DRd. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Researchers are evaluating the effects of intravenous ferric carboxymaltose FCM compared with a placebo on death risk, heart failure events, NT-proBNP levels, and quality of life in patients who recently had an acute myocardial infarction AMI and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled clinical trial aims to assess these outcomes over a follow-up period ranging from 8 to 36 months. Participants are randomly assigned to receive either an intravenous 15-minute infusion of 1000 mg FCM diluted in saline or a placebo infusion of saline alone. The first dose is given on the day of randomization, with follow-up visits at 4, 8, 12, 18, 24, and 30 months to reassess participants and possibly repeat treatment if safety criteria are met. During the study, participants undergo evaluations including monitoring of death rates, heart failure events such as unplanned hospitalizations or emergency visits, changes in NT-proBNP concentration, and quality of life measured by the EQ-5D questionnaire. Safety and treatment effects are tracked throughout the follow-up period, which can last up to 36 months from the start of participation.

Researchers are conducting an international multicenter prospective cohort study to gather information on breast reconstruction techniques using pre-pectoral implants after mastectomy for breast cancer. This observational study aims to collect data on surgical, aesthetic, and cancer-related outcomes, along with patients quality of life following this type of reconstruction. The study will include 1,236 female patients undergoing mastectomy for breast cancer followed by pre-pectoral implant-based breast reconstruction, which may involve implants or expanders with or without mesh. Since this is an observational study, patients medical and surgical care will not be altered, and no additional risks are expected. The research will evaluate the use of the pre-pectoral approach, including outcomes related to different surgical techniques and the impact of postmastectomy radiation therapy. Participants will be followed to assess outcomes such as implant loss, infections, readmissions, re-operations, and complications at various time points, including three months and up to 24 months after surgery. Quality of life will be evaluated at 0, 6, 12, and 24 months. The study will provide valuable data to guide future breast reconstruction decisions while keeping patient safety and well-being a priority.

Researchers are collecting detailed imaging and clinical data from patients with atrial fibrillation or atrial flutter who undergo transesophageal echocardiography to better understand and predict the risks associated with left atrial appendage thrombus LAT. This observational study aims to develop artificial intelligence models that analyze transthoracic echocardiography images and clinical information to predict the presence of LAT, which is linked to stroke risk and complicates cardioversion or catheter ablation procedures. The study involves gathering multimodal imaging data including transesophageal echocardiography, transthoracic echocardiography, cardiac CT, cardiac magnetic resonance, and electrocardiograms, both retrospectively and prospectively. Patients undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion. Optional imaging modalities and clinical data are collected to form a comprehensive database that supports AI-based model development and validation. Participants will have their imaging data and clinical records collected during hospitalization, with follow-up data on adverse outcomes and atrial fibrillation recurrence tracked for up to one year. Researchers will assess the presence of left atrial appendage thrombus using these data, aiming to improve diagnostic and therapeutic approaches. The study involves no treatment administration but focuses on detailed imaging acquisition and clinical monitoring to support artificial intelligence research.

Researchers are collecting and analyzing real-world data from multiple centers in Italy and Poland on the use of the PERCUTEK Tycheseal stent-graft system for repairing abdominal aortic aneurysms AAA. The study aims to evaluate the technical success, safety, and mid-term outcomes of this device in actual clinical practice. It focuses on patients with suitable anatomy undergoing this procedure, to provide evidence on the devices performance and related complications over time. This is an observational, physician-initiated registry enrolling 120 to 200 patients over about 18 months. Participants receive the PERCUTEK Tycheseal tri-modular endograft system, which includes a main body and two iliac limbs designed to fit a range of aortic anatomies. The device features a low-profile delivery system and radiopaque markers to aid placement. Data on the procedure and outcomes are collected without experimental treatments or randomization. Participants are followed for up to 24 months after device implantation with assessments at baseline, discharge, 1 month, 12 months, and 24 months. Study measures include technical success defined by proper device positioning and no immediate serious leaks, aneurysm size changes, endoleak presence, device migration or occlusion, and major adverse events. Data are collected using standardized forms, and safety outcomes are monitored throughout the study period to understand the devices mid-term clinical performance.

Researchers are evaluating the drug RVU120 for adult patients with intermediate or high-risk primary or secondary myelofibrosis, a type of bone marrow disorder. The study aims to assess how well RVU120 works alone or combined with ruxolitinib, focusing on its effectiveness, safety, how the body processes the drug, and its biological effects. This is a Phase 2 clinical trial sponsored by Ryvu Therapeutics SA, including patients who have been treated before or cannot use JAK inhibitors or had limited response to such treatments. Participants receive RVU120 at 250 mg every other day on specific days within 21-day treatment cycles, either as a single agent or combined with oral ruxolitinib taken twice daily according to usual dosing guidelines. The trial includes a screening period lasting up to 28 days, followed by treatment cycles, an end-of-treatment visit about 30 days after last dose, and a one-year follow-up phase with check-ins every three months. Doses may be adjusted as needed. During the study, participants undergo various assessments including symptom scoring, spleen size evaluation, blood tests for organ function, and monitoring for side effects. Researchers measure treatment response, symptom changes, spleen response duration, disease progression, survival, and adverse events over 12 months. Participants are monitored regularly and may withdraw anytime. The total study time varies depending on the number of treatment cycles each participant receives.

Researchers are evaluating the safety, tolerability, effectiveness, and how the body processes and responds to the drug RVU120 combined with venetoclax in adults with acute myeloid leukemia AML whose disease has returned or not responded after previous treatment with venetoclax and a hypomethylating agent. This Phase 2 study is divided into three parts first to find safe and tolerable doses, second to check safety and effectiveness of those doses, and third to confirm these findings in a larger group. In Part 1, participants receive increasing oral doses of RVU120 every other day and venetoclax daily in 21-day treatment cycles. The doses start at 125 mg for RVU120 and 200 mg for venetoclax and may increase based on safety and drug behavior. Part 2 uses the recommended doses from Part 1 to assess if the treatment meets target response goals. If successful, Part 3 treats more patients with those doses to further evaluate safety and effectiveness. Throughout the study, participants undergo regular assessments including safety checks, blood tests, and monitoring of treatment response over approximately 12 months for dose-finding and about 36 months for evaluating remission rates and other outcomes. Researchers track side effects, how long responses last, survival rates, and quality of life related to blood cancer symptoms. The study aims to better understand this combination treatments impact in adults with relapsed or refractory AML.

Researchers are evaluating fazirsiran, an investigational drug, to see if it can reduce liver scarring fibrosis and slow disease progression in people with liver disease caused by an abnormal alpha-1 antitrypsin protein. The study compares fazirsiran to a placebo and aims to understand how the drug affects the body, including its impact on liver inflammation and abnormal protein levels. Liver biopsies will be taken twice to assess changes in liver scarring. Participants will receive either fazirsiran or a placebo through subcutaneous injections. The dosing schedule includes an injection on Day 1, at Week 4, and then every 12 weeks up to Week 196. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo during the treatment period. During the study, participants will undergo liver biopsies and various assessments including imaging techniques and blood tests to monitor liver function, protein levels, liver stiffness, and inflammation. Researchers will also track side effects, lung function, vital signs, and laboratory results from the start of treatment through up to Week 230. The main focus is on measuring changes in liver fibrosis after 106 weeks, with ongoing safety and efficacy evaluations throughout the study.