Goch

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

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.

This research aims to evaluate the addition of venetoclax to standard induction and consolidation chemotherapy in adults newly diagnosed with acute myeloid leukemia AML or myelodysplastic syndrome with excess blasts-2 MDS-EB-2. It is a randomized, placebo-controlled, double-blind phase 3 clinical trial preceded by a dose-escalation feasibility phase to establish the venetoclax dose. The study is conducted across multiple centers and sponsored by the University of Ulm. Participants first undergo a feasibility run-in phase where venetoclax dosing is determined. Then, eligible patients are randomly assigned to receive either intensive chemotherapy combined with venetoclax or with a placebo. Treatment includes two cycles of induction chemotherapy followed by consolidation therapy based on initial randomization and established protocols. Patients achieving complete remission or certain other response states continue consolidation, and some may undergo allogeneic stem cell transplantation or other treatments depending on clinical factors. During the study, participants receive detailed evaluations including assessments of treatment safety and effectiveness. Researchers monitor event-free survival, dose-limiting toxicities, remission rates, relapse, survival, and quality of life using questionnaires and laboratory testing. Treatment adherence and safety are closely tracked. The study follows participants until at least 16 months after the last patient is enrolled, with some outcome measures extending to 28 months, to gather comprehensive data on treatment impact and patient health.

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.

Researchers are evaluating treatments for adults aged 18 to 65 with newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph ALL. This phase 2 multicenter trial, sponsored by Goethe University, aims to compare the current standard treatment of Imatinib plus low-dose chemotherapy with Ponatinib plus chemotherapy. It also seeks to explore different treatment strategies based on patients molecular response to therapy, including the use of Blinatumomab and the role of stem cell transplantation. Participants receive either Imatinib 600 mg once daily or Ponatinib 45 mg once daily reduced to 30 mg after induction, both combined with low-dose chemotherapy during induction and consolidation phases. Patients with a good molecular response are randomized to either end therapy with indication for stem cell transplantation or continue treatment with TKI, chemotherapy, and Blinatumomab. Those with poor molecular response receive Blinatumomab followed by end of therapy and transplantation indication. Stem cell transplantation itself is not part of the trial. During the study, participants undergo molecular evaluations for BCR-ABL1, regular monitoring of blood counts, and assessments of treatment response. Researchers measure overall survival in molecular complete remission patients receiving TKI-chemotherapy-Blinatumomab versus standard end of therapy with transplantation indication. Safety and remission rates are also tracked. The study involves follow-up for up to four years from randomization to assess long-term outcomes and treatment effects.

Researchers are conducting a registry study involving adult patients diagnosed with acute myeloid leukemia AML and related myeloid neoplasms, including newly diagnosed or relapsedrefractory cases. The study aims to collect comprehensive data on patient characteristics, family history, biological disease profiles, and clinical outcomes. It also focuses on analyzing disease-related genetic markers and the impact of measurable residual disease MRD using various methods. The study does not involve specific treatments but collects data and biological samples such as bone marrow, blood, plasma, and normal tissue including skin biopsies and other specimens. This observational study enrolls patients from around 80 to 90 sites in Germany and Austria. Patients treatment responses, decisions, and outcomes are tracked over time. Participants are observed for up to 10 years, during which researchers gather information on treatment response, survival, relapse rates, quality of life, and genetic markers. The study includes assessments of event-free survival, relapse-free survival, cumulative incidence of relapse and death, and overall survival. Patient consent is required for registration, data storage, and biobanking of specimens for analysis throughout the observation period.