Traunstein

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating the effectiveness and safety of a new drug combination called Mezigdomide (CC-92480) with bortezomib and dexamethasone (MeziVd) compared to an existing combination of pomalidomide, bortezomib, and dexamethasone (PVd). This study focuses on adults with relapsed or refractory multiple myeloma (RRMM) who have previously received between one and three lines of therapy, including prior lenalidomide treatment. The trial is a Phase 3, randomized, multicenter, open-label study aiming to improve outcomes for this condition. Participants will be assigned to receive either the MeziVd or PVd treatment regimen, with specified doses of each drug given on certain days. The study involves two treatment groups: one receiving mezigdomide, bortezomib, and dexamethasone, and the other receiving pomalidomide, bortezomib, and dexamethasone. Both regimens follow precise dosing schedules as determined by the study protocol. During the study, participants will be monitored regularly for disease progression or death, with the primary outcome being progression-free survival over up to approximately five years from the date of randomization. Ongoing assessments will include evaluations of safety and effectiveness. The total participation time may vary, and researchers will closely follow participants to gather detailed information on treatment responses and adverse effects.

Researchers are evaluating treatments for patients with generalized Mantle Cell Lymphoma in this Phase 3 trial. The study aims to identify one of three treatment approaches as a future standard by comparing failure-free survival, which measures the time from treatment start until stable disease, disease progression, or death. Secondary goals include assessing overall survival, progression-free survival, response rates, safety, and tolerability of the treatments, as well as exploring factors like minimal residual disease and stem cell mobilization. Participants receive one of three treatment plans: the control arm with alternating R-CHOP and R-DHAP chemotherapy followed by autologous stem cell transplantation (ASCT); an experimental arm adding ibrutinib during induction and maintenance with ASCT; or an experimental arm with ibrutinib during induction and maintenance without ASCT. Chemotherapy includes drugs such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, Ara-C, and cisplatin. Ibrutinib is given in certain induction cycles and as daily maintenance for two years. ASCT conditioning uses specific chemotherapy regimens or total body irradiation depending on the site. During the study, participants undergo regular assessments including imaging, laboratory tests, and evaluations of response and side effects. Researchers monitor failure-free survival up to 10 years, along with secondary outcomes like overall survival, progression-free survival, and safety events. Follow-up includes measuring molecular remission, relapse timing, and quality of life. The total duration includes treatment, maintenance, and long-term observation, with safety and efficacy carefully tracked throughout.

This research aims to collect ongoing safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis used by patients with lower extremity pareses. The study follows patients who have been casted for a C-Brace fitting and consent to participate, focusing on documenting their progress and experiences over time with this device. The C-Brace device includes custom thigh, calf, and foot components connected by an ankle joint and sensor system that continuously monitors knee joint movement. This allows the device to adjust resistance and control knee flexion and extension during walking. Participants will receive standard care including baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after final fitting. Participants will undergo assessments such as walking speed tests, mobility and balance evaluations, and balance confidence questionnaires to measure changes from baseline. The study also tracks device-related adverse events, especially falls, to monitor safety over 12 months and beyond. The total follow-up period extends up to 36 months to provide comprehensive data on long-term use.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy (LNE) improves overall survival in women with stage I or II endometrial cancer who have a high risk of recurrence. The study also aims to assess the impact of LNE on disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with confirmed high-risk endometrial cancer will be included in the trial. Participants will be randomly assigned to one of two groups. In the first group, patients will undergo a total hysterectomy and bilateral salpingo-oophorectomy, with an additional omentectomy if they have serous or clear cell cancer types. The second group will receive the same procedures plus systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein. This approach allows comparison between standard surgery and surgery with lymphadenectomy. During the study, patients will be monitored for overall survival over 60 months. Researchers will also evaluate disease-free survival and quality of life, while tracking complications and side effects of the treatments. Informed consent will be obtained, and patients’ compliance and health status will be regularly assessed. The trial includes close follow-up to observe long-term effects and outcomes of the surgical procedures.

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 effectiveness and safety of combining carboplatin, paclitaxel, bevacizumab, and niraparib compared to carboplatin and paclitaxel followed by niraparib alone in women newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase III international, multicenter, randomized open trial focuses on patients with specific advanced stages of these cancers who have undergone or plan to undergo surgery and chemotherapy. The study aims to see if adding bevacizumab to the treatment improves progression free survival. All participants first receive one cycle of chemotherapy with carboplatin and paclitaxel. Based on tumor BRCA testing, patients are then randomly assigned to one of two groups: one group receives five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years; the other group receives the same chemotherapy combined with bevacizumab, continuing bevacizumab for up to one year and niraparib daily for up to three years. Treatment schedules follow a three-week cycle. Participants will be closely monitored throughout the trial with frequent assessments to track progression free survival until either 586 events occur or three years after the last patient joins, whichever happens first. The study includes detailed safety evaluations, laboratory tests, and patient questionnaires. To participate, women must meet specific health criteria, including performance status and organ function, and agree to follow study procedures for up to three years of treatment and observation.

Researchers are evaluating real-world clinical data in women with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer who are receiving first-line treatment with Carboplatin, Paclitaxel, and Durvalumab (CPD). The study focuses on patients treated with CPD followed by maintenance therapy using either durvalumab alone or durvalumab combined with olaparib. This multi-center, prospective, non-interventional study aims to understand the effectiveness, safety, and patient-reported outcomes of these treatments in routine clinical practice in Germany. Participants receive first-line CPD chemotherapy after surgery and/or radiation if applicable. Following this, maintenance therapy is given with durvalumab for patients with DNA mismatch repair deficient tumors (dMMR cohort) or with durvalumab plus olaparib for those with DNA mismatch repair proficient tumors (pMMR cohort). Treatment decisions are made jointly by patients and their physicians as part of standard care, independent of the study itself. During the study, data on treatment effectiveness and safety will be collected along with patient-reported outcomes after the chemotherapy phase. Researchers will monitor real-world time to the next treatment over 12 months. Patients will complete questionnaires and their tumor mismatch repair status must be known. The study includes women aged 18 years or older and involves regular follow-ups to gather comprehensive information about the treatment effects and patient experience.

Researchers are collecting new real-world data on first-line treatment for women newly diagnosed with advanced high-grade epithelial ovarian cancer in Germany. This study aims to understand how maintenance treatment with Poly ADP ribose polymerase inhibitors (PARPi) affects routine medical care, patient outcomes, and treatment sequences, especially in those undergoing surgery and chemotherapy. It also explores patient-reported experiences, physician insights, genetic testing practices, and drug safety in this setting. The study observes patients receiving first-line platinum-based chemotherapy, including those who have completed primary debulking surgery. It includes patients who have started or are planning to start chemotherapy, with the total number of chemotherapy cycles tailored by the treating physician. Women of childbearing potential must use reliable contraception during the study. The study does not involve any experimental interventions but monitors treatments as they occur in regular clinical practice. Participants will be followed to evaluate progression-free survival and other outcomes up to 84 months from the start of chemotherapy. Patient-reported outcomes will be collected electronically to capture experiences and needs during and after maintenance therapy. The study also tracks the use of BRCA/HRD testing, treatment safety, and physician experiences to better understand care patterns and long-term results in routine clinical settings.