Goch

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are collecting detailed information on adults diagnosed with Acute Lymphoblastic Leukemia (ALL) and related blood cancers such as other leukemias and certain types of Non-Hodgkin's Lymphoma. The purpose is to gather real-world data on diagnosis, treatments, and outcomes to support ALL research and improve quality of care. This registry includes patients whether or not they are part of other clinical trials. Participants included in this registry are adults aged 18 and older diagnosed with ALL or similar leukemias who are treated according to established ALL treatment protocols. It also includes patients with specific subtypes of Non-Hodgkin's Lymphoma treated according to B-ALL protocols. The study involves collecting clinical data and biological samples over time to understand treatment responses and disease progression. Throughout the study, researchers will monitor participants' health outcomes, including overall survival for up to 10 years. Data collected will cover diagnostics, treatments received, and patient outcomes in routine clinical care. This long-term follow-up aims to provide valuable insights into the effectiveness of current therapies and patient experiences with these blood cancers.

Researchers are evaluating the use of venetoclax combined with induction and consolidation chemotherapy in adults newly diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2). This phase III, multicenter, double-blind, randomized, placebo-controlled study aims to establish the effectiveness and safety of adding venetoclax to standard chemotherapy compared to placebo. The study includes a feasibility run-in dose-escalation phase to determine the appropriate venetoclax dose for the main phase 3 trial. Eligible patients will first enter a dose-escalation phase if applicable, then be randomized to receive either venetoclax or placebo along with intensive chemotherapy. Treatment includes two induction chemotherapy cycles with cytarabine and daunorubicin, followed by consolidation chemotherapy based on age and response. Patients achieving complete remission or morphologic leukemia-free states may continue consolidation therapy. Some patients may also proceed to allogeneic stem cell transplantation based on institutional guidelines and individual factors. Participants will be closely monitored for events such as survival without leukemia relapse and treatment toxicities over 6 and 16 months. Safety assessments include tracking dose-limiting toxicities during the first treatment cycle. The study also involves molecular testing, kidney and liver function tests, and adherence to contraceptive measures for participants of childbearing potential. The total study participation duration varies based on treatment response and follow-up needs.

Researchers are studying pre- and perimenopausal women with estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer who have an intermediate to high clinical risk but low genomic risk of recurrence based on MammaPrint4 testing. The study aims to understand the real-world use of ovarian function suppression (OFS) combined with endocrine therapy, with or without prior chemotherapy, and how secondary amenorrhea after chemotherapy might affect outcomes. It also focuses on treatment adherence and quality of life over time, given the importance of long-term endocrine treatment up to 10 years. The registry will follow patients receiving standard-of-care treatment, which may include endocrine therapy with or without ovarian function suppression, and potentially chemotherapy based on clinical decisions. Data on treatment choices, including the use of OFS and chemotherapy, will be collected along with tumor characteristics assessed by local pathology and genomic signatures. Quality of life assessments will be conducted at baseline and multiple time points up to five years, while treatment adherence and outcomes will be tracked over up to 10 years. Participants will provide baseline information including tumor and treatment details. Researchers will collect follow-up data on treatment adherence, quality of life using specific questionnaires, and disease outcomes such as the five-year distant recurrence-free interval. Monitoring will include hormonal status and clinical assessments to correlate treatment effects with genomic risk scores and clinical markers. The overall goal is to improve understanding of treatment patterns and outcomes in this specific breast cancer population under real-world conditions.

Researchers are studying adult patients with newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) to evaluate different treatment approaches involving tyrosine kinase inhibitors (TKIs) combined with low-dose chemotherapy. The trial aims to compare Ponatinib versus Imatinib, both combined with chemotherapy, and to assess different strategies based on patients' molecular response to therapy. The study challenges the current standard of care by examining alternative treatments for patients who respond well or poorly to initial therapy. Participants receive either Imatinib at 600 mg once daily with chemotherapy or Ponatinib at 45 mg once daily with chemotherapy. Patients with molecular failure or intermediate response receive one cycle of Blinatumomab before stem cell transplantation (SCT). Those who achieve molecular complete remission (CR) and are randomized to the experimental arm receive three cycles of Blinatumomab plus chemotherapy, while patients in the standard arm or with molecular failure or intermediate response have an indication for SCT. The trial includes randomization to different treatments and a non-randomized Blinatumomab treatment for suboptimal responders. During the study, participants will be monitored for overall survival up to four years from randomization. Molecular evaluations for BCR-ABL1 are performed to guide treatment decisions, and safety is closely observed. Patients must consent to participate in a registry and agree to contraception requirements if applicable. Clinical assessments include performance status, blood tests, and cardiac monitoring. The study involves multiple centers and aims to gather long-term data on survival outcomes and treatment effectiveness.

This research focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related myeloid neoplasms. It aims to register all patients treated at approximately 80-90 sites in Germany and Austria, capturing comprehensive data on patient characteristics, family history, biological disease features, and clinical outcomes. The study also seeks to analyze genetic markers related to the disease and evaluate treatment responses and survival outcomes over an extended period. Patients enrolled in the study will have their disease-related genetic markers analyzed rapidly to inform treatment recommendations. Biosamples such as bone marrow, blood, plasma, skin biopsy, fingernails, hair, sputum, or urine will be collected and stored for further analysis. The study intends to assess measurable residual disease using various methods and correlate biological markers with clinical outcomes. Participants will be observed for up to 10 years, during which researchers will monitor event-free survival, relapse-free survival, cumulative incidence of relapse and death, overall survival, and quality of life. Treatment decisions, response to therapy, and geographical representation will also be recorded. Data collection includes clinical assessments and storage of biosamples, with ongoing evaluation of disease progression and patient outcomes throughout the study period.