Wolfsburg

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.

Researchers are collecting data in a registry study for adults diagnosed with acute myeloid leukemia AML, including newly diagnosed and relapsed cases. The study aims to gather important information about the diseases epidemiology, such as patient age and prognostic factors, and to compare incidence and age distribution with population tumor registry data. It also evaluates key clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival. This observational study does not involve treatment assignment but documents treatment strategies used by patients. Data is gathered over a 10-year period to thoroughly monitor outcomes and disease patterns. The registry also collects information on complete remission rates, treatment-related mortality, therapy-associated morbidity, and quality of therapy and diagnosis. Additionally, the study seeks to validate known prognostic factors and explore new ones while describing new therapies and supportive care measures. Participants are adults aged 18 years and older diagnosed with AML according to WHO criteria, including acute promyelocytic leukemia. The study involves long-term follow-up with yearly assessments over 10 years. Researchers will evaluate epidemiological parameters and important survival outcomes. Since this is an observational registry, participants continue with their usual care while data is collected. The study is sponsored by Technische Universitt Dresden and involves multiple sites in Germany.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.

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 detailed clinical and biological data from children and adults diagnosed with rare brain tumors, including medulloblastoma, ependymoma, pineal tumors, and choroid plexus tumors. This international registry aims to improve understanding of these rare diseases, support quality assurance networks, and enhance collaboration across countries. The registry focuses on patients treated outside of clinical trials to help establish standard treatment recommendations and counseling. Participants provide information on tumor characteristics, treatment details, and biological samples such as tumor tissue, cerebrospinal fluid, and blood. The registry evaluates disease causes, molecular risk factors, and potential targets for future drug treatments. It also monitors the use of quality assurance systems during diagnosis and treatment and supports long-term follow-up studies on survival, neuropsychology, and patient-centered outcomes. During participation, patients contribute data over time, allowing researchers to track clinical courses and treatment responses. The registry assesses long-term outcomes including event-free survival, relapse patterns, and overall survival for up to 10 years. Ethical approval and informed consent are required, ensuring data is collected responsibly. This ongoing observational study provides valuable insights to improve care for patients with these rare brain tumors.

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.

Researchers are evaluating the addition of letrozole, an aromatase inhibitor, to the standard maintenance therapy in women diagnosed with estrogen-receptor ER positive epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. This study focuses on both low and high grade serous or endometrioid ovarian cancers at FIGO Stage II-IV, whose cancer has not progressed after primary surgery and platinum-based chemotherapy. The main goal is to determine if letrozole can increase progression-free survival compared to the current standard maintenance treatment with placebo. Participants are randomly assigned to receive either letrozole 2.5 mg daily or a placebo tablet once daily for up to five years or until toxicity symptoms or disease progression occur. This randomized, double-blinded, multicenter phase III trial involves 540 eligible women who will be monitored throughout the treatment period. The study also includes a sub-study focusing on low grade ovarian cancer LOGOS. Treatment adherence and tolerability will be assessed during regular visits. Participants will undergo health assessments including blood tests, physical and gynecological exams, and possibly imaging during routine follow-ups every 12 weeks for the first two years, then every 24 weeks for three additional years. Quality of life will be evaluated using specific questionnaires, and participants will wear an activity tracker for one week before visits. Researchers will measure progression-free survival as the primary outcome and also evaluate overall survival, time to next treatment, and quality-adjusted survival. Follow-up data will be collected for up to 12 years, including up to seven years after treatment ends to monitor long-term outcomes.

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.