Paderborn

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 treatments for patients with high risk chronic lymphocytic leukemia (CLL), a common and aggressive form of leukemia. This phase 3, open-label, randomized study aims to compare a triple combination therapy of acalabrutinib, obinutuzumab, and venetoclax (GAVe) against a double combination of obinutuzumab and venetoclax (GVe) to see which better prolongs progression-free survival (PFS). High risk CLL patients are identified by specific genetic risk factors such as 17p-deletion, TP53-mutation, complex karyotype, or unmutated IGHV gene status, which indicate a poorer prognosis and less response to chemotherapy. Participants receive fixed-duration treatments. The triple combination group receives obinutuzumab via intravenous infusion during cycles 1 through 6, venetoclax orally with a gradual dose ramp-up from cycle 1 to 12, and acalabrutinib orally twice daily during cycles 15 to 24. The comparison group receives obinutuzumab and venetoclax on the same schedules but without acalabrutinib. The study investigates how adding the BTK inhibitor acalabrutinib to the existing combination may improve outcomes by targeting different pathways and reducing early disease progression. During the study, participants are closely monitored for progression-free survival over 50 months after the first patient is included. Researchers assess clinical status, laboratory tests, and genetic markers to evaluate response and safety. The study also tracks liver and kidney function, infection status, and adverse events to ensure treatment tolerability. The total duration includes initial treatment cycles and extended follow-up to measure the long-term effectiveness of these therapies in high risk CLL patients.

This research aims to compare intismeran autogene combined with pembrolizumab versus placebo with pembrolizumab as an additional treatment after surgery for people with stage II, IIIA, or IIIB (with nodal involvement) non-small cell lung cancer (NSCLC) that has been fully removed with clear margins. The study is a phase 3 trial investigating whether the combination including intismeran autogene improves disease-free survival compared to the placebo combination. Participants will receive either intismeran autogene by intramuscular injection plus pembrolizumab by intravenous infusion or a placebo injection plus pembrolizumab. The treatments are given after surgery and standard platinum-based chemotherapy. No more than 24 weeks can pass from surgery to the first pembrolizumab dose. The study evaluates these treatments as adjuvant therapy to reduce cancer recurrence. During the trial, researchers will monitor participants for disease-free survival for up to approximately 78 months. Participants undergo regular assessments including medical evaluations to track cancer status and treatment effects. The study excludes those with prior neoadjuvant therapy, certain infections, or other cancer treatments that might interfere. Safety and long-term outcomes are carefully observed throughout the study period.

Researchers are evaluating the safety and effectiveness of inavolisib combination treatments in women with untreated, early-stage (Stage II-III), PIK3CA-mutated breast cancer. This cancer is estrogen receptor (ER)-positive and Human Epidermal Growth Factor Receptor 2 (HER2)-negative. The study is a Phase II, open-label, multicenter trial focusing on these specific breast cancer characteristics. Participants will receive inavolisib combined with other drugs, including ribociclib and letrozole, administered according to specific schedules defined in the study. These treatments are given before surgery (neoadjuvant therapy) to assess their impact on the cancer. After completing the treatment period, participants who are operable will undergo breast surgery, such as mastectomy or breast-conserving surgery. During the study, researchers will monitor participants for adverse events from the first dose until 30 days after the last dose, covering approximately 8 months. Assessments include safety evaluations and measuring treatment effects on the cancer. Participants will be closely followed to gather data on the safety and overall response to the combination therapies throughout the study period.

Researchers are evaluating the addition of Acalabrutinib to the standard R-miniCHOP treatment in older adults with untreated diffuse large B-cell lymphoma (DLBCL). This phase 3 study aims to determine if adding Acalabrutinib can extend progression-free survival compared to R-miniCHOP alone. Participants include men and women aged 61 years and older who are either over 80 or deemed ineligible for full-dose R-CHOP chemotherapy. Participants will be randomly assigned to receive either R-miniCHOP alone or R-miniCHOP combined with Acalabrutinib. The R-miniCHOP treatment involves intravenous rituximab, cyclophosphamide, doxorubicin, vincristine, and oral prednisolone given in cycles every three weeks. In the combination group, Acalabrutinib tablets are taken twice daily continuously from day 1 of the first cycle through day 21 of cycle 8. During the study, participants will undergo regular evaluations including clinical assessments and laboratory tests. The main outcome measured is progression-free survival, tracked for up to 5 years. Researchers will monitor safety and treatment effects throughout the study period, with participants involved in all required procedures and follow-ups according to the study plan.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are evaluating the clinical performance of a new Plasma Filter PX2 used in therapeutic plasma exchange (TPE) treatments for patients with autoimmune diseases. This study collects treatment data to understand how the Plasma Filter PX2 works when combined with devices called multiFiltrate and multiFiltratePRO. The purpose is to observe its use in real-world clinical practice without changing the usual treatment plans prescribed by doctors. This is a one-arm study focusing only on patients treated with the Plasma Filter PX2. The study involves documenting up to 230 TPE treatments, which corresponds to about 46 patients receiving on average 5 to 7 treatments each. The Plasma Filter PX2 is used once per treatment in combination with the multiFiltrate or multiFiltratePRO devices for blood purification. Treatments are given as decided by the treating physician, with no specific schedule required by the study protocol. The study reflects normal clinical use rather than a controlled treatment plan. Participants will have their treatments and related information recorded up to the 10th treatment. Researchers will analyze the treatments over an average period of about 7 weeks, depending on individual patient needs and treatment frequency. The study includes monitoring for safety and effectiveness of the Plasma Filter PX2 during these TPE procedures, collecting data to contribute to evidence about this new device's performance in clinical settings.

The DiamondTemp Global Registry is a prospective, multi-center, observational post-market study focused on patients with arrhythmia. It aims to collect clinical performance and safety data from a wide range of patients treated with the commercially available DiamondTemp Family of Cardiac Ablation Catheters. Participants will be followed for at least 12 months after their procedure to monitor outcomes according to standard care practices at their institutions. Participants will undergo a cardiac ablation procedure using the DiamondTemp Ablation System. This device is used during the planned procedure as part of routine clinical care. There is no comparison group, as this is an observational registry collecting real-world data on the device's use. The study does not specify additional treatment phases or interventions beyond the procedure. During the study, participants will be followed for a minimum of 12 months post-procedure. Researchers will collect data on freedom from arrhythmia recurrence and any device or procedure-related adverse events during this period. Follow-up aligns with standard clinical practice, allowing assessment of both safety and effectiveness outcomes in a real-world setting.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

The trial investigates treatment options for patients with Richter Transformation (RT), a challenging progression of chronic lymphocytic leukemia (CLL) with poor prognosis and limited effective therapies. RT patients often respond poorly to conventional chemoimmunotherapy, and many are not suitable candidates for allogeneic transplantation. This phase II trial aims to assess the safety and effectiveness of combining zanubrutinib, a BTK inhibitor, with tislelizumab, a PD-1 inhibitor, with or without sonrotoclax, a Bcl-2 inhibitor, to improve outcomes in this patient group. Participants receive treatment in cycles every 21 days. Zanubrutinib is taken orally twice daily at 160 mg. Tislelizumab is administered intravenously at 200 mg on day 1 of each cycle. For those receiving sonrotoclax, there is an initial ramp-up phase during cycle 1 with increasing doses from 2 mg to 320 mg daily, followed by a maintenance dose of 320 mg daily from cycle 2 to cycle 6. The study evaluates the combination of these drugs systematically to monitor safety and treatment response. During the study, participants undergo regular assessments including evaluations of overall response rate after 18 weeks based on refined Lugano Classification criteria. Researchers monitor safety, toxicity, and efficacy through clinical visits, laboratory tests, and imaging as needed. Patients must meet specific health criteria and provide informed consent to participate. The trial includes ongoing monitoring for adverse effects and treatment adherence over the course of therapy to better understand the potential of these drug combinations for RT.