Hagen

This observational study follows patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study is non-interventional and open-label, designed to collect real-world data on treatment and disease progression over several years. It aims to understand how patients continue their baseline treatments and how these treatments impact various health and quality of life measures. Participants receive routine medical care with approved injectable or oral DMTs such as ofatumumab, interferon b21, glatiramer acetate, teriflunomide, dimethyl fumarate, or diroximel fumarate. The study includes two cohorts with up to approximately two years of prospective observation each, with an optional extension allowing up to four years total. Treatment decisions and monitoring follow the patients usual care and physicians discretion, including routine visits and telemedicine options. During the study, participants provide medical history, complete questionnaires, and have data collected on disability status, MRI findings, relapses, and laboratory tests. Researchers assess treatment continuation rates, fatigue, anxiety, depression, quality of life, lesion counts, and relapse rates at multiple time points. Safety and treatment interruptions are also documented. Follow-up is flexible and based on standard care procedures, with data collection occurring throughout the observational periods.

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating treatments for patients with high-risk chronic lymphocytic leukemia CLL, a type of blood cancer that is aggressive and currently incurable. This phase 3, open-label, multicenter, randomized study aims to compare the effectiveness of a triple drug combination acalabrutinib, obinutuzumab, and venetoclax against a double combination obinutuzumab and venetoclax in prolonging progression-free survival PFS for patients with specific high-risk genetic features such as 17p-deletion, TP53 mutation, complex karyotype, or unmutated IGHV gene status. The study addresses a crucial medical need for better treatments in this difficult-to-treat group. Participants will be randomly assigned to one of two treatment groups. One group receives the triple combination of acalabrutinib, obinutuzumab, and venetoclax, while the other group receives obinutuzumab plus venetoclax. Obinutuzumab is given as intravenous infusions on specific days across six cycles. Venetoclax is taken orally with a carefully planned dose escalation and maintenance over 12 cycles. Acalabrutinib is administered orally twice daily during cycles 15 to 24. The study explores whether adding acalabrutinib improves outcomes by using these fixed-duration, chemotherapy-free regimens. Throughout the study, participants will undergo regular assessments to monitor response and safety, including checks for minimal residual disease MRD and overall survival. These evaluations occur up to 50 months after the first patient is enrolled. Researchers will also track progression-free survival, complete and overall response rates, event-free survival, duration of response, and time to next treatment. Safety monitoring and laboratory tests will be performed as part of study visits. The total study participation is expected to last several years to capture long-term outcomes for this high-risk patient population.

Researchers are studying atrial tachycardia AT that occurs after ablation of atrial fibrillation AF or cardiac surgery. This condition is difficult to treat due to the complex nature of the heart tissue and the mechanisms causing AT. The study aims to compare two methods of catheter ablation for ATstandard versus minimalized approachesto see which leads to better arrhythmia-free survival. The trial is prospective, randomized, and conducted at multiple centers to improve understanding using new ultra-high-density mapping techniques. Participants will receive catheter-based ablation using radiofrequency to treat their AT. They will be randomly assigned to either a standard ablation approach or a minimalized ablation approach targeting the clinical AT. The study will evaluate various procedural details such as procedure duration, fluoroscopy time, radiofrequency application time, ablated heart area, and the number of blocked lines. Both groups will be monitored during the procedure with advanced mapping techniques to assess the underlying heart substrate and AT mechanisms. During the study, participants will undergo assessments including ECG documentation of AT, intraprocedural mapping, and evaluations of arrhythmia recurrence over one year. Researchers will measure the recurrence of sustained arrhythmia lasting more than 30 seconds as the primary outcome after one year. Other measures include inducibility of AT after ablation, predictability of secondary AT from mapping, and procedure-related parameters. Participants will be followed for safety and treatment effectiveness throughout the study period, which started in December 2020 and is expected to continue until June 2027.

Researchers are evaluating two pacing methodsleft bundle branch area LBBA pacing and right ventricular RV pacingin patients with atrial fibrillation who have preserved left ventricular function. This study aims to compare the effects of these pacing techniques after AV node ablation, focusing on clinical, functional, and electrical heart outcomes. The main question is whether RV pacing causes more pacing-induced cardiomyopathy, defined as a significant decline in heart function, compared to LBBA pacing. Secondary goals include assessing procedural safety, heart function, quality of life, and functional capacity. Participants will undergo either LBBA pacemaker implantation or RV apical pacemaker implantation before AV node ablation. This is a randomized, single-blind trial where patients are assigned to one of these two procedures. Both methods involve device implantation prior to the scheduled AV node ablation, which is performed independently of the study. The study follows patients for 36 months to observe long-term effects and safety. During the study, patients will be monitored for changes in heart function using echocardiography and other clinical assessments. Researchers will measure outcomes such as left and right ventricular function, heart strain, serum biomarkers, quality of life through a validated questionnaire, walking distance, mortality, and rehospitalizations related to heart failure, pacemaker issues, or arrhythmias. Safety outcomes and stroke events will also be tracked. This comprehensive follow-up lasts three years to thoroughly evaluate the impact of the pacing methods.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

Researchers are collecting long-term clinical follow-up data on patients with multiple myeloma who previously took part in therapy studies conducted by the German-Speaking Myeloma Multicenter Group GMMG. The study focuses on tracking overall survival, progression-free survival, and follow-up time to better understand the outcomes of these patients. This national registry gathers comprehensive data from multiple centers in Germany, combining therapy study results with ongoing patient information for scientific research. This is an observational, non-interventional registry that includes retrospective and prospective data on multiple myeloma patients. It incorporates basic patient data, diagnosis details, therapies received, and long-term follow-up information. Patients are observed continuously while receiving standard care until death, loss to follow-up, or withdrawal of consent. Follow-up information is collected every six months until the first disease progression and annually thereafter, using a secure, pseudonymized database with automated data checks. Participants contribute data through routine clinical visits without receiving experimental treatments. The study measures progression-free survival at 5 years and beyond, overall survival, causes of death, and therapy-free intervals after relapse. Data collection includes regular clinical monitoring and centralized oversight to ensure accuracy. This registry supports ongoing research by providing detailed long-term outcome data for multiple myeloma patients, with no limit on sample size and participation expected to continue until the study ends in 2027.

Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation ASCT. The study compares a combination of iberdomide and isatuximab with iberdomide alone to determine if adding isatuximab reduces measurable myeloma cells in the bone marrow after two years. This is a multicenter, randomized, open phase III trial building on prior treatments from the GMMG-HD8DSMM XIX trial or similar regimens. Participants are randomly assigned to one of two groups. One group receives oral iberdomide alone for 39 cycles, each lasting 29 days, with dexamethasone added during the first cycle. The other group receives the same iberdomide regimen plus subcutaneous isatuximab injections using a wearable injector system, with dexamethasone also given in the first cycle. Treatment continues for up to 36 months. Randomization considers factors like minimal residual disease MRD status and the number of transplantations. During the study, participants will undergo bone marrow assessments to measure MRD using next-generation flow cytometry. Researchers will monitor progression-free survival, overall survival, response rates, and quality of life using validated questionnaires. Safety and treatment effects will be followed for up to five years after randomization. Participants will have regular evaluations including laboratory tests and clinical assessments throughout the maintenance period and follow-up.

Immune thrombocytopenia ITP is a rare blood disorder caused by an autoimmune condition that reduces platelet counts, increasing the risk of bleeding or prolonged bleeding. New treatments for ITP have emerged recently, but existing clinical studies are limited in their applicability to everyday patient care due to strict criteria. This registry aims to collect real-world clinical data and biospecimens from patients with various types of ITP to improve understanding of diagnosis, therapy, and patient outcomes in routine treatment. The registry includes patients diagnosed with primary or secondary ITP who consent to participate. Data collection occurs at defined points in the disease course either prospectively or retrospectively up to 12 months after diagnosis, provided continuous documentation is available. Biospecimens are collected and stored systematically to support research. Clinical information collected includes disease characteristics, treatment types, complications, quality of life, fatigue scores, and survival data over a follow-up period of up to 5 years. Participants provide clinical data and biosamples at enrollment, then again at 6 months and annually for up to 5 years. Assessments include platelet counts, bleeding and thromboembolic events, laboratory markers such as specific antibodies, and patient-reported outcomes like quality of life and fatigue. The study gathers epidemiological data on incidence, age, sex distribution, causes of ITP, treatment received, and remission status. The registry helps advance knowledge about ITP through long-term monitoring and standardized data collection.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.